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Adverse Event Report

BAXTER HEALTHCARE CORP SPINAL ANESTHESIA TRAY   back to search results
Catalog Number 2T2323
Event Date 04/30/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Nurse anesthetist called and reported that a pt who had received spinal anesthesia in preparation for a cesarean section experienced signs and symptoms of "meningitis. " it was reported that the evening following the procedure, the pt complained of headache, developed a fever (actual temperature unknown) and experienced nuchal rigidity. The nurse anesthetist stated a lumbar puncture was performed and the cerebral spinal fluid was examined and cultured. It was reported that the pt was started on an "unknown" antibiotic and within 24 hours had completely recovered. It was provided that the the pt was discharged home 72 hours after the procedure with no sequelae.

 
Manufacturer Narrative

A two-year review of the product-reporting database reveals this to be an isolated report for this code and lot. The batch review for lot gd796599 showed no defects were noted during the mfg process and that all routine release criteria for components and the entire batch were met.

 
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Brand NameSPINAL ANESTHESIA TRAY
Type of DeviceSPINAL ANESTHESIA TRAY
Baseline Brand NameSPINAL ANESTHESIA TRAY
Baseline Generic NameSPINAL ANESTHESIA TRAY
Baseline Catalogue Number2T2323
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BAXTER HEALTHCARE CORP
911 n davis
cleveland MS 38732
Manufacturer (Section D)
BAXTER HEALTHCARE CORP
911 n davis
cleveland MS 38732
Manufacturer (Section G)
BAXTER HEALTHCARE CORP
911 north davis
cleveland MS 38732
Manufacturer Contact
jenny baethke, assistant mgr
route 120 & wilson rd
round lake , IL 60073
(847) 270 -6496
Device Event Key517301
MDR Report Key528115
Event Key501327
Report Number6000001-2004-00817
Device Sequence Number1
Product CodeCAZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/03/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/01/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/15/2005
Device Catalogue Number2T2323
Device LOT NumberGD796599
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/03/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/01/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1 FENTANYL 01/01/2004
2 ASTRAMORPH 01/01/2004
3,AND BUPIVICAINE FROM OTHER MANUFACTURERS, UNK TO,01/01/2004
4,BAXTER, 2004.,01/01/2004

Database last updated on December 31, 2008

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