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Adverse Event Report

COBE/GAMBRO/HOSPAL GAMBRO HEMODIALYZER   back to search results
Model Number 1CSN
Patient Outcome  Required Intervention;
Event Description

Facility alleges blood leak during dialysis. Estimated blood loss 250cc. No reported complications. Treatment restarted without further incident.

 
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Brand NameGAMBRO
Type of DeviceHEMODIALYZER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
COBE/GAMBRO/HOSPAL
1201 oak street
lakewood CO 80215
Manufacturer (Section D)
COBE/GAMBRO/HOSPAL
1201 oak street
lakewood CO 80215
Device Event Key24165
MDR Report Key23828
Event Key22100
Report Number23828
Device Sequence Number1
Product CodeFJI
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/27/1993
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/1993
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number1CSN
Device Catalogue Number0121145
Device LOT Number30562N11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/1993
Distributor Facility Aware Date12/20/1993
Event Location Outpatient Treatment Facility
Date Report TO Manufacturer12/27/1993
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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