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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 01/01/2003
Event Type  Malfunction  
Event Description

The facility's biomedical technician reported an infusion pump with failure code 26. Although attempts were made by baxter to obtain additional information from the reporting facility, details were not available regarding pt status, medical intervention, pt injury, age of pt, medication involved or the set up of the infusion device. The hospital rep stated they have no record of any pt incident involving the pump since the last baxter service event. No additional 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 evaluation, or if any additional details become available. This report represents all information 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 avenue
skokie IL 60076
Manufacturer (Section D)
BAXTER/SABRATEK CORP
8111 n. st. louis avenue
skokie IL 60076
Manufacturer (Section G)
BAXTER HEALTHCARE (SG)
2 woodlands industrial park d
singapore
SINGAPORE 9612057
Manufacturer Contact
joanne celba
route 120 & wilson road
round lake , IL 60073
(847) 270 -4696
Device Event Key430426
MDR Report Key441451
Event Key417878
Report Number6000001-2003-01312
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/07/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2003
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 Manufacturer01/13/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/07/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/1997
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 February 28, 2009

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