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Adverse Event Report

ABBOTT LABORATORIES LIFECARE PCA PLUS INFUSER PCA INFUSION PUMP   back to search results
Catalog Number 01950
Device Problem Self-activation/keying
Event Date 12/01/2003
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Report received of an unrequested bolus dose delivery. The pump was programmed in the pca only mode to deliver demerol 10mg/ml, with a 10mg pca dose, a 6-minute pt lockout, and a 300mg 4-hour limit. Therapy was initiated on an unspecified date. The customer reported that on the date therapy began, the pt had informed the night shift nurse that when the pendant was pushed, the pump would not deliver a dose, but when the pendant was not pushed, the pump would deliver a dose. The night shift nurse assessed the pump and did not note any unusual pump activity. At approx 9:00am the next day, the pt informed the day shift nurse that when the pendant was pushed, the pump would not deliver a dose, but when the pendant was not pushed, the pump would deliver a dose. The nurse pushed the pendant and no delivery occurred. After an unspecified length of time, the nurse decided to replace the pump, and while taking the pendant from the pt, the pump audibly beeped and delivered an unrequested dose. The customer reported that the pt did not get more medication than pt should have. There were no reported adverse pt effects and no medical interventions were required. 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.

 
Search Alerts/Recalls

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Brand NameLIFECARE PCA PLUS INFUSER
Type of DevicePCA INFUSION PUMP
Baseline Brand NameLIFECARE PCA PLUS INFUSER
Baseline Generic NameINFUSION PUMP
Baseline Catalogue Number01950
Baseline Device FamilyPUMP, INFUSION
Baseline Device 510(K) NumberK895710
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed08/26/2001
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.
200 abbott park rd
dept. 389 bldg. j-45
abbott park , IL 60064-6132
(847) 935 -3715
Device Event Key497190
MDR Report Key508242
Event Key482111
Report Number2921482-2004-00002
Device Sequence Number1
Product CodeMEA
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/22/2003
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 Number01950
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/22/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/1988
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

Database last updated on January 30, 2009

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