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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS HEMOCARE NETHERLANDS B.V. FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR; COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET
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FRESENIUS HEMOCARE NETHERLANDS B.V. FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR; COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET Back to Search Results
Model Number N/A
Device Problems Insufficient Flow or Under Infusion (2182); Appropriate Term/Code Not Available (3191); Component Misassembled (4004)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2020
Event Type  malfunction  
Event Description
Patient underload.
 
Event Description
Patient underload intensive care unit, blood backflow in the substitute at the start of an exchange with comtec.The pump insert (the white one) is set up upside down.Received 2 pictures, on the pictures is clearly visible that the connection of the pump is exchanged.Identified root cause: assembly failure.Result of risk assessment: potential hazard / hazardous situation: tube glued into wrong port of the pump adapter patient underload.Severity of the harm: catastrophic.Occurrence of the harm: improbable.
 
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Brand Name
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
Type of Device
COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET
Manufacturer (Section D)
FRESENIUS HEMOCARE NETHERLANDS B.V.
runde zz 41
emmer-compascuum, NL-78 81 H
NL  NL-7881 HM
MDR Report Key10164939
MDR Text Key205472059
Report Number3002807758-2020-00001
Device Sequence Number1
Product Code LKN
Combination Product (y/n)N
PMA/PMN Number
K060734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 05/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number9400401
Device Lot NumberKAT 071
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/25/2020
Event Location Hospital
Date Report to Manufacturer05/25/2020
Date Manufacturer Received05/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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