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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT, INC. COBE 2991 CELL PROCESSING SET; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

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TERUMO BCT, INC. COBE 2991 CELL PROCESSING SET; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC Back to Search Results
Catalog Number 90819
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  malfunction  
Event Description
During the washing procedure of a bone marrow product on the cobe 2991, a small tear formed at the exit port of the bag.
 
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Brand Name
COBE 2991 CELL PROCESSING SET
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
Manufacturer (Section D)
TERUMO BCT, INC.
10811 west collins ave
lakewood CO 80215
MDR Report Key7572940
MDR Text Key110224395
Report Number7572940
Device Sequence Number1
Product Code LKN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2019
Device Catalogue Number90819
Device Lot Number08A15001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/30/2018
Device Age7 MO
Event Location Hospital
Date Report to Manufacturer05/30/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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