PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE— 510(k) K081412
Substantially EquivalentHospira, Inc.
FDA 510(k) clearance K081412 for PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE, Substantially Equivalent on 2008-12-17. Applicant: Hospira, Inc.. Device class: 2.
Clearance details
- Applicant
- Hospira, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, IL, US
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More clearances from Hospira, Inc.
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K081412
K-number listed on FDA's recall record- Z-1074-2015 — The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.
- Z-2722-2016 — Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
- Z-2723-2016 — Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
- Z-2724-2016 — Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
- Z-2725-2016 — Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
- Z-2726-2016 — Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
- Z-2727-2016 — Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
- Z-2728-2016 — Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
- Z-2729-2016 — Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
- Z-2730-2016 — Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
- Z-0283-2014 — The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Hyperbaric Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
- Z-0626-2013 — Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
- Z-0482-2013 — Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
- Z-0203-2014 — Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081412.
Data sourced from openFDA. This site is unofficial and independent of the FDA.