MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 14.5FX28CM HEMO-FLOW

Model Number HFS28E.

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/16/2022

Event Type  Death  

Manufacturer Narrative

Additional information has been requested.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient passed away during the dialysis process.

Manufacturer Narrative

The device involved in the incident was not available for evaluation.The catheter was implanted for 5 months without any reported prior malfunction.Without an evaluation of the catheter involved, we are unable to determine the cause of the event.However, since the catheter was implanted for 5 months with no reported problems, it is unlikely to be manufacture related.Information provided by the facility indicated that the incident occurred 9 minutes into the treatment.The report also stated that "dialysis lumens from the cvc catheter were still connected to the patient, both the arterial and venous lumens were in place, the arterial lumen was pushed in and luer locked securely.The venous limb was pushed in but noticed not to be luerlocked." it is possible that there was blood loss at the connection of the catheter and bloodlines due to the incomplete connection.The female luers are manufactured to the iso standard (iso 594-2:1998).They are universal female luers and will mate with any universal male luer of the bloodlines, syringes, injection caps, etc.If they are also manufactured to the iso standard.The blood lines, not manufactured by medcomp, should also be evaluated.The instructions for use include the following catheter precautions.Examine catheter lumen and extensions before and after each treatment for damage.To prevent accidents, assure the security of all caps and bloodline connections prior to and between treatments.Use only luer lock (threaded) connectors with this catheter.Hemodialysis treatment instructions include the follow.Before dialysis begins all connections to catheter and extracorporeal circuits should be examined carefully.Frequent visual inspection should be conducted to detect leaks to prevent blood loss or air embolism.If a leak is found, the catheter should be clamped immediately.Necessary remedial action must be taken prior to the continuation of the dialysis treatment.Note: excessive blood loss may lead to patient shock.

• Brand Name: 14.5FX28CM HEMO-FLOW
• Type of Device: HEMO-FLOW
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 15624741
• MDR Text Key: 301914599
• Report Number: 2518902-2022-00062
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HFS28E.
• Device Catalogue Number: HFS28E.
• Device Lot Number: MQAF030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: LIFELINE BETA AV-SET 5008 CORDIAX POST-R BLOOD LIN
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 64 KG