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 Problems Insufficient Flow or Under Infusion (2182); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/18/2019

Event Type  malfunction  

Event Description

Patient underload.

Event Description

Patient underload: 2 pictures received.On the pictures it is visible that the tubing assembled to the transparent pump have been exchanged.The identified root cause is an isolated assembly failure during manufacturing.A capa was opened, closed and implemented.

• 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 Key: 9130460
• MDR Text Key: 196620651
• Report Number: 3002807758-2019-00001
• 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: 08/19/2019

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 Number: N/A
• Device Catalogue Number: 9400408
• Device Lot Number: HET023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1