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Adverse Event Report

BAXTER / SABRATEK CORP. SABRATEK 3030 PUMP INFUSION PUMP   back to search results
Model Number 3030
Event Date 04/03/2001
Event Type  Malfunction  
Event Description

Pump was returned for service with report that it was "infusing too high". Further info received from the facility revealed that the pump failed an accuracy test during routine preventive maintenance in the biomed shop, there was no pt involved and were no reports of pt injury or medical intervention related to this device. The pump was reportedly set to a rate of 500ml/hr and was set to deliver 45ml. The measured output of the pump after this testing was reported to be 48ml.

 
Manufacturer Narrative

This device was received and tested for accuracy, during that testing it was found to deliver up to 19. 5% above the desired volume. The accuracy specification for this device is +-5%. This overdelivery was caused by a misalignment of the pump mechanism encoder wheel on the pump drive mechanism. It is not known what caused the misalignment to occur, there was no record of the device being serviced by the mfr prior to this event and there was no evidence of any other internal damage to the device. Quality management will continue to monitor reports of this nature and take further action as appropriate.

 
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Brand NameSABRATEK 3030 PUMP
Type of DeviceINFUSION PUMP
Baseline Brand NameSABRATEK 3030 PUMP
Baseline Generic NameINFUSION PUMP
Baseline Catalogue Number2M9845
Baseline Model Number3030
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BAXTER / SABRATEK CORP.
8111 n. st. louis ave
skokie IL 60076
Manufacturer (Section D)
BAXTER / SABRATEK CORP.
8111 n. st. louis ave
skokie IL 60076
Manufacturer Contact
joanne celba
route 120 & wilson road
round lake , IL 60073
(847) 270 -4696
Device Event Key378671
MDR Report Key389629
Event Key367958
Report Number6000001-2002-00316
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/19/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number3030
Device Catalogue Number2M9845
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/05/2001
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/03/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/1997
Is The Device Single Use? 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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