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

Model Number 03-2622-3

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/10/2020

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 user facility nurse reported a blood leak that occurred at the two to five minutes after starting the patient¿s hemodialysis (hd) treatment.The date of event was initially reported as (b)(6) 2020, however was not confirmed during follow up.The blood leak was visually observed at the joining of the arterial line to the heparin line, and it was reported that the bloodlines were broken.There was no other damage or defect seen on the bloodlines.The machine, a fresenius 4008s, did not alarm.There were no issues noted during priming.The patient¿s estimated blood loss (ebl) was unknown.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine after setting up with new supplies.The complaint devices were discarded and are not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: twenty four companion samples were received with the original package.The companion samples were visually inspected.The joining of the tubing between the heparin and pump tee were closely inspected and found acceptable, with no defect such as separation or absent of solvent.In addition, the rest of the bloodline arterial and venous line was inspected and found acceptable.The companion sample was tested on the hemodialysis machine 2008k for simulated use and no disconnection or leaks occurred during tested period from the heparin line to the red "t" connector.No air bubbles inside the system was noticed.There were no leaks, no level variation of venous and arterial chamber or any alarm.The sample tested worked as intended without any abnormalities during the tested period.A device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation of the actual sample could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• 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: 10320688
• MDR Text Key: 200617308
• Report Number: 8030665-2020-01031
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 20BR01059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Device Age: MO
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 4008S MACHINE
• Patient Age: 44 YR
• Patient Weight: 80