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Adverse Event Report

COBE CARDIOVASCULAR, INC. PERFUSION MAJOR PACK CUSTOM PERFUSION PACK   back to search results
Catalog Number 078107004
Device Problem Separates
Event Date 05/10/2000
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Just as the perfusionist was almost finished emptying the blood from the bag, the spike line separated from the spike. Two to three cc's of blood spilled onto the machine and the perfusionist. No add'l blood needed to be given to the pt to compensate for the loss. The perfusionist did not suffer any ill effects.

 
Manufacturer Narrative

A1, a2) the hosp contact could not provide this info. H6) the spike in this custom perfusion pack has been changed to another spike that should provide a stronger bond with the spike line.

 
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Brand NamePERFUSION MAJOR PACK
Type of DeviceCUSTOM PERFUSION PACK
Baseline Brand NamePERFUSION MAJOR PACK
Baseline Generic NameCUSTOM PERFUSION PACK
Baseline Catalogue Number078107004
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)34
Date First Marketed01/06/1998
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 Contact
mary armstrong, manager
14401 w. 65th way
arvada , CO 80004-3599
(303) 467 -6521
Device Event Key272580
MDR Report Key281679
Event Key264196
Report Number1718850-2000-00015
Device Sequence Number1
Product CodeDWE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 05/10/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/01/2003
Device Catalogue Number078107004
Device LOT Number03F0068
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/10/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2000
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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