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Adverse Event Report

BAXTER/SABRATEK CORP. SABRATEK 6060 HOMERUN PUMP SABRATEK 6060 PUMP   back to search results
Model Number 2M9832
Event Date 02/01/2003
Event Type  Malfunction  
Event Description

The facility's biomedical technician reported an infusion pump with failure code 9, found during biomed testing. The hosp representative stated they have no record of any pt incident involving the pump since the last baxter service event. No add'l contact info was provided.

 
Manufacturer Narrative

The pump is in the process of being evaluated. A follow-up report will be filed upon completion of the eval, or if any add'l details become available. This report represents all info known by the reporter at this time.

 
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Brand NameSABRATEK 6060 HOMERUN PUMP
Type of DeviceSABRATEK 6060 PUMP
Baseline Brand NameSABRATEK 6060 HOMERUN PUMP
Baseline Generic NameSABRATEK 6060 PUMP
Baseline Catalogue Number2M9832
Baseline Model Number2M9832
Baseline Device FamilySABRATEK 6060 PUMP
Baseline Device 510(K) NumberK941984
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed05/01/1995
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 Key437969
MDR Report Key448985
Event Key425134
Report Number6000001-2003-03584
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/19/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number2M9832
Device Catalogue Number2M9832
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/18/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/19/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/1999
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 06, 2009

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