MAUDE Adverse Event Report: FRESENIUS HEMOCARE GMBH FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

Model Number N/A

Device Problem Pumping Problem (3016)

Patient Problem Unspecified Heart Problem (4454)

Event Date 07/11/2023

Event Type  Death  

Event Description

Per fresenius kabi france, a report was received of an unconscious patient admitted for plasma exchange.The team mounted a pl1 kit (material: 940401c, batch: mlt 161) on the comtec (material: c9008021, serial: (b)(6) and proceeded with the purge.All went well.The registered nurse validated the steps on the comtec up to the patient connection phase.The registered nurse connected the inlet and return lines to the patient's catheter and set up the saline drip.Normally, the procedure can then be started, but the team was waiting for bags of fresh frozen plasma as a substitute liquid to start the procedure.After an estimated 20 minutes, with the procedure still to be started, the patient began to experience heart problems.The team attended to the patient, investigating the possible causes of the malaise in relation to the patient's pathology and the medication administered.After an estimated 60 minutes, the team disconnected the patient, at which point they realized that the acd bag was completely empty.The patient died.No alarm was triggered on the device.A test was performed, and the drip was very weak.Upon examining the unit, it was noted there was a problem with the pump head of the acd pump on the comtec device; a plastic part seemed to be broken.The device has been taken out of service while this event is under investigation.Note: the comtec device material: c9008021 is not marketed in the us.However, a similar device material: 9008031 is marketed in the us under 510k k060734.

• Brand Name: FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
• Type of Device: FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
• Manufacturer (Section D): FRESENIUS HEMOCARE GMBH; gruener weg 10; friedberg hessen, D-611 69; GM D-61169
• Manufacturer (Section G): FRESENIUS HEMOCARE GMBH; gruener weg 10; friedberg hessen, D-611 69; GM D-61169
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502300
• MDR Report Key: 17591209
• MDR Text Key: 321617985
• Report Number: 3004634229-2023-00001
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: C9008021
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death