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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 04/10/2003
Event Type  Malfunction  
Event Description

The baxter service technician reported an infusion pump with failure code 7, found during service. The hosp rep 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 reported condition of failure code 7 was confirmed. An inspection of the device revealed the root cause to be a malfunctioning motor assembly.

 
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Brand NameSABRATEK 6060 HOMERUN PUMP
Type of DeviceSABRATEK 6060 PUMP
Baseline Brand NameSABRATEK 6060 HOMERUN PUMP
Baseline Generic NameSABRATEK 6060PUMP
Baseline Catalogue Number2M9832
Baseline Model Number2M9832
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 (Section G)
BAXTER HEALTHCARE CORPORATION
17511 armstrong ave.
irvine CA 92614
Manufacturer Contact
joanne celba
route 120 & wilson road
round lake , IL 60073
(847) 270 -4696
Device Event Key444258
MDR Report Key455276
Event Key431211
Report Number6000001-2003-05267
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/10/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2003
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 Manufacturer04/09/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/10/2003
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 February 28, 2009

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