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Adverse Event Report

ABBOTT LABORATORIES PLUM A+ INFUSION PUMP   back to search results
Catalog Number 11971
Device Problem Overdelivery
Event Date 09/10/2003
Event Type  Injury   Patient Outcome  Life Threatening; Required Intervention
Event Description

Report received of an overdelivery. The pump was reportedly prgrammed in the dose calculation mode to deliver diprivan 10mg/ml at a dose of 10mcg/kg/min. The nurse stated that the pump display indicated that the infusion being delivered was "10mcg/kg/min" when the infusion was started. Approximately one minute later, the pump sounded an alarm for distal occlusion. The nurse unhooked the primary tubing line from the pt's iv cannula and flushed the line with 10cc of normal saline. The infusion was restarted after the tubing was reconnected to the pt line. Approximately 15 minutes later, the pump sounded an alarm for proximal air-in-line. At this time, the nurse noted the diprivan bottle, which had contained 90 ml, was empty. The nurse reported that the pump display indicated that the pump was infusing "on regular mode and not on the therapy mode" they had programmed. The physician was paged. Upon arrival, the physician noted the pt was bradycardic and hypotensive. The pt was "successfully resuscitated". There were no reported adverse pt sequelae. Although requested, there was no additional info provided.

 
Manufacturer Narrative

The pump was received 10/14/2003. Testing and investigation are not complete. The pump history was printed at the manufacturer facility. The pump history indicated that the pump continued to be used after the reported event date; therefore, the event log on event date was overwritten by subsequent info.

 
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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 drive
morgan hill CA 95037
Manufacturer Contact
thomas sampogna, assoc. director
200 abbott park road
dept. 389, bldg. j-45
abbott park , IL 60064-6132
(847) 935 -3715
Device Event Key479006
MDR Report Key490265
Event Key464791
Report Number2921482-2003-00533
Device Sequence Number1
Product CodeFPA
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 09/23/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number11971
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/14/2003
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received09/23/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2002
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: 10/17/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,PLUM A+ SOFTWARE MODULE, LIST #12393,,
2,DIPRIVAN, MANUFACTURED BY NOVA PLUS.,

Database last updated on December 31, 2008

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