MAUDE Adverse Event Report: FRESENIUS HEMOCARE NETHERLANDS B.V. FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR; COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET

Model Number N/A

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Date 10/09/2018

Event Type  malfunction  

Event Description

Potential patient underdose.

Event Description

Potential patient underdose.A picture was received for evaluation.The picture shows that the tubing assembled to the transparent pump have been exchanged.The tube was glued into the wrong port of the pump adapter.The identified root cause is an assembly failure during manufacturing.A capa was opened to investigate this issue.There was no deviation related to the assembly failure found in the batch review.

• 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 Key: 8046369
• MDR Text Key: 128256638
• Report Number: 3002807758-2018-00003
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K060734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

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 Model Number: N/A
• Device Catalogue Number: 9400401
• Device Lot Number: HAT 171
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2018
• Event Location: Other
• Date Report to Manufacturer: 10/11/2018
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1