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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 10/19/2003
Event Type  Other   Patient Outcome  Other;
Event Description

Report received of an underdelivery. The customer contact indicated that the event was the result of an error in programming the device. The pump was programmed in the dose calculation mode to deliver dopamine 9. 1mg/100ml, instead of the intended concentration of 912mg/100ml. The remaining programmed parameters were unspecified. At the time of the event, the pt was classified as "unstable", but the customer contact indicated it was unspecified whether the pt's instabiity was the result of the programming error or the pt's post-op status. There were no reported adverse pt sequlae. 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 pump history was printed at the user facility. A review of the pump history indicated that at 1020 the pump was programmed in the dose calcualtion mode, with a concentration of 9. 1mg, diluent 100ml, a dose of 3 mcg/kg/min, for a duration of 13 hours and 20 minutes, a volume to be infused (vtbi) of 100ml, and a calculated rate of 7. 5ml/hr and the delivery was started. The pump continued to deliver at this programmed concentraion until the pump was powered off at 1423. A review of the pump history indicated the pump delivered as programmed. This report represents all the info known by the reporter upon query by abbott personnel.

 
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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 associate direct
200 abbott park road
dept. 389 bldg. j-45
abbott park , IL 60064-6132
(847) 935 -3715
Device Event Key487206
MDR Report Key498459
Event Key472648
Report Number2921482-2003-00586
Device Sequence Number1
Product CodeFPA
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/24/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2003
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 Received10/24/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/01/2001
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: 11/18/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,PLUM A+ SOFTWARE MODULE, LIST #12393.,

Database last updated on January 30, 2009

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