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Adverse Event Report

ABBOTT LABORATORIES PLUM A+ INFUSION PUMP   back to search results
Catalog Number 11971
Device Problems Programming calculations, incorrect; Device, incorrect care/use of
Event Date 02/25/2004
Event Type  Other   Patient Outcome  Other;
Event Description

Report received of an overdelivery. The customer contact indicated that the event was the result of an operator error in programming the device. In 2004 at 0100, the pump was programmed to deliver 25000 units of heparin in 250ml at a rate of 30ml/hr instead of the intended rate of 11ml/hr. At 0550, the nurse noted the error. The pump was reprogrammed to deliver at the intended rate of 11ml/hr, but the nurse powered off the pump after "about 2 minutes. " a ptt was drawn and found to be "outside the baseline. " there were no reported medical interventions required. The pump was removed from clinical service. Though requested, no additional information was provided.

 
Manufacturer Narrative

The device is expected to be returned for testing and investigation. It has not yet been rec'd. The history indicated that in 2004 at 0049 the pump was programmed in the ml/hr mode to deliver at a rate of 11ml/hr with a vtbi (volume to be infused) of 68. 5ml for a duration of 6 hours and 14 minutes. At 0050, the pump was titrated to deliver at a rate of 30ml/hr for a duration of 2 hours and 16 minutes and the delivery was started. At 0306 the pump alarmed that the vtbi was complete. The pump was reprogrammed to deliver a vtbi of 400ml at the same rate of 30ml/hr. At 0627, the pump was titrated to deliver at a rate of 11ml/hr with a vtbi of 299. 5ml for a duration of 27 hours and 13 minutes and the delivery was started. At 0629, the device was powered off. A review of the history indicates that the deivce delivered as intended.

 
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Brand NamePLUM A+
Type of DeviceINFUSION PUMP
Baseline Brand NamePLUM A+
Baseline Generic NameADMINISTRATION SET
Baseline Catalogue Number11971
Baseline Device FamilySET, ADM, INTRAVASCULAR
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed01/12/1999
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, assoc. director
200 abbott park rd
dept. 389, bldg. j-45
abbott park , IL 60064-6132
(847) 935 -3715
Device Event Key530387
MDR Report Key541059
Event Key513794
Report Number2921482-2004-00175
Device Sequence Number1
Product CodeFPA
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/04/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11971
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2004
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: 03/22/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,PLUM A+ SOFTWARE MODULE, LIST #12393.,

Database last updated on January 30, 2009

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