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Adverse Event Report

COBE RENAL CARE, INC. GAMBRO LUNDIA, ALPHA 500 PLATE DIALYZER PLATE DIALYER   back to search results
Catalog Number N01847004
Patient Outcome  Other;
Event Description

Between 7/31/95 and 9/1/95, 7 pts incurred blood losses of approx 125 cc each when blood leaks occurred on the plate dialyzer.

 
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Brand NameGAMBRO LUNDIA, ALPHA 500 PLATE DIALYZER
Type of DevicePLATE DIALYER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
COBE RENAL CARE, INC.
1185 oak dr
lakewood CO 80215 4407
Device Event Key28490
MDR Report Key27573
Event Key25770
Report NumberMW1007516
Device Sequence Number1
Product CodeFJG
Report Source Voluntary
Report Date 10/04/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/1995
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberN01847004
Device LOT Number5-0510-N 50512N11
Was Device Available For Evaluation? No
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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