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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 06/01/2020
Event Type  malfunction  
Event Description
Patient underload.
 
Event Description
Patient underload.The operator installed the kit without problems.At the end he started the priming of the circuit which did not signal any alarm.After connecting the patient, the operator started the procedure and a few seconds after com.Tec continuously signaled "low infusion pressure" alarm.By carefully checking the assembly of the kit they noticed that the drip chambers of the replacement fluids line filled completely because the pump segment (white connector) were glued in the opposite position.The white pump pumps in the direction of replacement fluids (see photo attached).Received 2 pictures, on the pictures it is visible that the tubing assembled to the transparent pump have been 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 Key10164951
MDR Text Key199892601
Report Number3002807758-2020-00002
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 06/03/2020
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 NumberICT 272
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/03/2020
Event Location Hospital
Date Report to Manufacturer06/03/2020
Date Manufacturer Received06/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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