MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2622-3

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A hemodialysis (hd) clinic administrator reported to fresenius mexico that the combi set clamps were not occluding and were allowing the passing of blood.It was reported the staff had to use another set of clamps to avoid the issue.Upon follow-up with the clinic, it was reported there was patient blood loss.It was reported that the patient completed their treatment.It was reported the patient lost in-between 100 to 150 ml of blood.It was reported the actual device was discarded but representative samples were available to be returned to the manufacturer for evaluation.Additional information was requested, but was reported to be unavailable.

Manufacturer Narrative

Plant investigation: representative samples were returned to the manufacturer for evaluation.All the samples were visually inspected and were found to be within specification.The arterial and venous lines were closely reviewed and no damages were observed.A functional test was performed on two companion samples utilizing the hemodialysis machine 2008t for simulated use and it was observed that fluid from the blood line was returning back through the saline tubing with the closed clamp on the saline line.During the evaluation of the samples, the alleged failure stated in the complaint was confirmed.The device history record (dhr) of this product was reviewed and no nonconformance reports or other abnormalities during the assembly of this lot  were found.The product involved was released meeting specifications.

• Brand Name: COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 9406720
• MDR Text Key: 169221400
• Report Number: 8030665-2019-01844
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 19ER01247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Device Age: MO
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1