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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 Problem Improper Flow or Infusion (2954)
Patient Problem No Information (3190)
Event Date 02/20/2018
Event Type  malfunction  
Event Description
Customer reported during rbc procedure the replacement fluid line is taking the fluid in a reverse way (from the air detector chamber to replacement fluid bag).A technician went to the customer and checked the pl1 set.After close and accurate checking it was observed that the white pump line segment was glued in a reverse way so that instead of withdrawing the replacement fluid from replacement fluid bag to the air detector chamber, it is taking the fluid from air detector chamber and inserting it into the replacement fluid bag.
 
Event Description
Customer reported during rbc procedure the replacement fluid line is taking the fluid in a reverse way (from the air detector chamber to replacement fluid bag).A technician went to the customer and checked the pl1 set.After close and accurate checking it was observed that the white pump line segment was glued in a reverse way so that instead of withdrawing the replacement fluid from replacement fluid bag to the air detector chamber, it is taking the fluid from air detector chamber and inserting it into the replacement fluid bag.The manufacturer received 4 pictures for evaluation.On the pictures received, it is visible that the tubing assembled to the transparent pump have been exchanged.The assignable cause was determined to be an assembly failure during manufacturing.
 
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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, drenthe NL-78 81 H
NL  NL-7881 HM
MDR Report Key7363696
MDR Text Key103430353
Report Number3002807758-2018-00001
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 02/21/2018
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 Other
Device Model NumberN/A
Device Catalogue Number9400401
Device Lot NumberGBT 133
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/21/2018
Event Location Other
Date Report to Manufacturer02/21/2018
Initial Date Manufacturer Received 02/21/2018
Initial Date FDA Received03/22/2018
Supplement Dates Manufacturer Received02/21/2018
Supplement Dates FDA Received10/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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