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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS HEMOCARE GMBH CATSMART; CATSMART ATF 40 FAST START KIT WITH AT3
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FRESENIUS HEMOCARE GMBH CATSMART; CATSMART ATF 40 FAST START KIT WITH AT3 Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 08/27/2019
Event Type  malfunction  
Event Description
Disconnected processed red cell (prc) pump tubing during emergency wash cycle.
 
Event Description
Disconnected processed red cell (prc) pump tubing during emergency wash cycle.Received a blood-filled at-3 of batch iat 222.Investigation of the complaint sample shows that the prc pump tube has been disconnected from pump adapter.Remains of glue is visible, and tube was inserted far enough.The prc got disconnected during emergency wash.Catsmart was in use from 9:30 until +/-16h.After a few minutes, since emergency protocol was activated, the pump tube got disconnected.The root cause was identified as an assembly failure during manufacturing.Most likely not enough glue was used.
 
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Brand Name
CATSMART
Type of Device
CATSMART ATF 40 FAST START KIT WITH AT3
Manufacturer (Section D)
FRESENIUS HEMOCARE GMBH
gruener weg 10
friedberg hessen, D-611 69
GM  D-61169
MDR Report Key9117783
MDR Text Key191744306
Report Number3004634229-2019-00003
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
PMA/PMN Number
K160735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 08/28/2019
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 Other
Device Model NumberN/A
Device Catalogue Number9108493
Device Lot NumberIBT 203
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/28/2019
Event Location Other
Date Report to Manufacturer08/28/2019
Initial Date Manufacturer Received 08/28/2019
Initial Date FDA Received09/25/2019
Supplement Dates Manufacturer Received08/28/2019
Supplement Dates FDA Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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