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ABBOTT LABORATORIES LIFECARE PLUM XL PUMP INFUSION PUMP   Back to Search Results
Catalog Number 11555
Event Date 10/01/1999
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Testing and investigation performed at an international testing site confirmed the complaint of an independent rate change with a defective battery and down revision software. Both conditions, loss of power and down revision software, caused the complaint experience for independent rate change. Subsequent software release detects defective battery, defaults set rate and volume settings to zero and activates "check setting" alarm.

 
Manufacturer Narrative

The pump is expected to be returned to a foreign service center for testing and investigation. This report represents all the info known by the reporter upon query by abbott personnel.

 
Event Description

A report was received from abbott international affiliate (abbott canada) of a spontaneous/independent rate change. The report states "pump was set to deliver 71ml/hr of tpn. The pt went for a walk and the pump was on battery power. The pump went blank and the pump was then plugged into the wall. This is when the rate switched from 71ml/hr to 500ml/hr. The change in rate was noticed immediately; therefore there was no overdelivery of tpn. The tpn was then discontinued and the pt was receiving dextrose and 10% water. " there was no additional info available.

 
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Brand NameLIFECARE PLUM XL PUMP
Type of DeviceINFUSION PUMP
Baseline Brand NameLIFECARE PLUM XL PUMP
Baseline Generic NameINFUSION PUMP
Baseline Catalogue Number11555
Baseline Device FamilyPUMP, INFUSION
Baseline Device 510(K) NumberK953660
Is Baseline PMA Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/01/1993
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
frank pokrop, assoc director
dept 389, ap30
200 abbott park rd
abbott park , IL 60064-6157
(847) 937 -8473
Device Event Key243952
MDR Report Key251892
Event Key236134
Report Number2921482-1999-00240
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation NOT APPLICABLE
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/21/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11555
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/21/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1994
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/19/1999 Patient Sequence Number: 1
#TreatmentTreatment Date
1,UNK
 
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