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Adverse Event Report

COBE CARDIOVASCULAR, INC. PERFUSION PACK CUSTOM PERFUSION PACK   back to search results
Catalog Number 078327-004
Event Date 09/08/1997
Event Type  Malfunction   Patient Outcome  Other;
Event Description

The subject cobe perfusion pack was found to have the inlet arterial line connected to the outlet port of the oxygenator membrane compartment. The problem was detected at setup, so there was no patient involvement. The customer indicated that the same problem had been found at setup in 5 other packs from this lot as well.

 
Manufacturer Narrative

H. 3) the entire lot of product was received at cobe cardiovascular and a sample perfusion pack was evaluated. As expected, the inlet arterial line was connected to the outlet port on the membrane compartment of the oxygenator. This was in improper configuation and was due to the blueprint for the product being improperly drawn. The blueprint has been redrawn to show the correct configuration.

 
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Brand NamePERFUSION PACK
Type of DeviceCUSTOM PERFUSION PACK
Baseline Brand NamePERFUSION PACK, BAXTER PERFUSION SERVICES FLORIDA MEDICAL CENTER, SAN DIEGO,CA
Baseline Generic NameCUSTOM PERFUSION PACK
Baseline Catalogue Number078327-004
Baseline Device FamilyCUSTOM PERFUSION PACK
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)23
Date First Marketed08/26/1997
Manufacturer (Section F)
COBE CARDIOVASCULAR, INC.
14401 west 65th way
arvada CO 80004 3599
Manufacturer (Section D)
COBE CARDIOVASCULAR, INC.
14401 west 65th way
arvada CO 80004 3599
Manufacturer (Section G)
SORIN GROUP USA, INC.
14401 west 65th way
arvada CO 80004
Manufacturer Contact
mary armstrong
14401 w. 65th way
arvada , CO 80004-3599
(303) 467 -6521
Device Event Key119799
MDR Report Key122318
Event Key115003
Report Number1718850-1997-00016
Device Sequence Number1
Product CodeDWE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Recall,Inspection
Type of Report Initial,Followup
Report Date 09/08/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/22/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/01/2000
Device Catalogue Number078327-004
Device LOT Number09C0205
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/19/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/08/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1997
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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