MAUDE Adverse Event Report: MEDCOMP 14.5FX28CM HEMO-FLOW; HEMO-FLOW HEMODIALYSIS CATHETER

Model Number HFS28E.

Device Problem Disconnection (1171)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 01/06/2018

Event Type  Death  

Event Description

During dialysis, it was identified that blood was coming out of the access port.The venous return line from the dialysis machine was identified as becoming disconnected from the patient's catheter.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation.No pictures were provided.The device lot number was sent to the contract manufacture to perform a device history record review.The review indicated that the luer assembly operation was performed within established requirements.The luers used to for this device were inspected as part the incoming inspection process and were accepted.Reported product lot was manufactured within specification according to the applicable drawing and design requirements.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.The catheter had been implanted for 9 months with no previous incidents.The catheter was used for 9 months, the bloodlines are new every treatment.The issue may have been with the bloodlines (manufactured by fresenius, not medcomp).

• Brand Name: 14.5FX28CM HEMO-FLOW
• Type of Device: HEMO-FLOW HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7685763
• MDR Text Key: 113910750
• Report Number: 2518902-2018-00045
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908017373
• UDI-Public: 884908017373
• Combination Product (y/n): N
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/20/2019
• Device Model Number: HFS28E.
• Device Catalogue Number: HFS28E.
• Device Lot Number: MHPD030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death