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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

Patient underload.Fresenius kabi received a complaint for a quantity of 10 as the customer reviewed 1 device and did not inspect the other 9 that they received.The entire quantity on hand was listed in the complaint.No sample or pictures were received for evaluation.

Event Description

Patient underload.Fresenius kabi received a complaint for a quantity of 10 as the customer reviewed 1 device and did not inspect the other 9 that they received.The entire quantity on hand was listed in the complaint.No sample or pictures were received for evaluation.Per the initial customer report, the 1 reviewed device had impaired glueing of one of the pump segments - it is mounted in reverse.Not all kits have this defect, it occurs at random.No patient injury has been reported.Fresenius kabi received 2 pictures from the customer.Within the pictures, the connection exchange of the system tubing to the pump tubing of the transparent pump adapter is clearly visible.Fresenius kabi investigation: potential hazard / hazardous situation: tube glued into wrong port of the pump adapter potential harm: patient underload.Severity of the harm: catastrophic.Occurrence of the harm: improbable.Fresenius kabi's investigation not this is an isolated finding.Describe assignable cause: assembly failure.Fresenius kabi corrective/preventive action: an assembly tool has been implemented with the transparent pump adapter, to exclude a connection exchange.This was implemented (b)(6) 2019.This complaint is on a batch after the change.This will be monitored in production process and an awareness training has been given.

• 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
• Manufacturer (Section G): FRESENIUS HEMOCARE NETHERLANDS B.V.; runde zz 41; emmer-compascuum, drenthe NL-78 81 H; NL NL-7881 HM
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502300
• MDR Report Key: 13010176
• MDR Text Key: 285749525
• Report Number: 3002807758-2021-00001
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 11/19/2021

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: 9400401
• Device Lot Number: KAT 071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1