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Adverse Event Report

ABBOTT LABORATORIES ABBOTT PLUM A+ INFUSION PUMP   back to search results
Catalog Number 12391
Device Problem Overdelivery
Event Date 01/30/2004
Event Type  Injury   Patient Outcome  Life Threatening; Required Intervention
Event Description

Report received of an overdelivery. In 2004, the pump was programmed to deliver "12mun of pitocin in an unspecified amount of solution at a rate of 473ml/hr instead of the intended rate of 72ml/hr. " the nurse left the room for "a moment" and when she returned, the fetal monitor indicated that the pt was having tetantic contractions. The infusion was stopped and the physician was notified. The pt was treated with 0. 25mg of tebutaline subcutaneously. There were no reported adverse mother or fetal sequelae. Though requested, no additional info was provided.

 
Manufacturer Narrative

Testing and investigation could not confirm the customer's reported event of an overdelivery. Testing was conducted using the customer's reported protocol. The device passed all tests including delivery accuracy. The pump history was downloaded and printed at the mfg site. The pump history indicated in 2004 at 1411, the pump was programmed in the dose calculation mode to deliver in mun/minute with a concentration of 10 units, diluent 1000ml, at a dose of 72mun/minute at a calcuated rate of 432ml/hr, with a vtbi (volume to be infused) of 603ml, for a duration of 1 hour and 23 minutes, and the delivery was started. At 1414, the device was powered off. A review of the history indicated that the device delivered as programmed.

 
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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 associate dir.
dept. 389 bldg. j-45
200 abbott park rd
abbott park , IL 60064-6132
(847) 935 -3715
Device Event Key501944
MDR Report Key512937
Event Key486680
Report Number2921482-2004-00099
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/30/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number12391
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/11/2004
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/30/2004
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2000
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: 02/24/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,PLUM A+ SOFTWARE MODULE, LIST# 12097.,

Database last updated on December 31, 2008

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