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Adverse Event Report

ABBOTT LABORATORIES ABBOTT PLUM A+ INFUSION PUMP   back to search results
Catalog Number 12391
Device Problem Underdelivery
Event Date 12/01/2003
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Report received of an underdeliver. The pump was returned from clinical service with an unsigned note that read, "b pump not working. It is working too slow. At 30 minutes, med takes one hour. " the note did not provide any tracking info; therefore, specific pt info, pump programming or event details were not available. There were no reported adverse pt events. Though requested, no additional info was provided.

 
Manufacturer Narrative

H10: the device is expected to be returned for investigation. It has not yet been received. The device event history was downloaded at the user facility. Review of the history showed no unusual entries.

 
Search Alerts/Recalls

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Brand NameABBOTT PLUM A+ INFUSION PUMP
Type of DeviceINFUSION PUMP
Baseline Brand NameABBOTT PLUM A+ INFUSION PUMP
Baseline Generic NameINFUSION PUMP
Baseline Catalogue Number12391
Baseline Device FamilyPUMP, INFUSION
Baseline Device 510(K) NumberK024084
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed12/31/2002
Manufacturer (Section F)
ABBOTT LABORATORIES
755 jarvis dr.
morgan hill CA 95037
Manufacturer (Section D)
ABBOTT LABORATORIES
755 jarvis dr.
morgan hill CA 95037
Manufacturer (Section G)
ABBOTT LABORATORIES
755 jarvis dr.
morgan hill CA 95037
Manufacturer Contact
thomas sampogna, director
200 abbott park road
dept. 389 bldg. j-45
abbott park , IL 60064-6132
(847) 935 -3715
Device Event Key497197
MDR Report Key508251
Event Key482118
Report Number2921482-2004-00005
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 12/12/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/05/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number12391
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/12/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2002
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 01/05/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,PLUM A+ SOFTWARE MODULE LIST# 12097.,

Database last updated on February 28, 2009

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