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 06/04/2020

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 biomedical technician (biomed) reported a blood leak occurred at an unknown time of the patient¿s hemodialysis (hd) treatment.The blood leak was visually observed at the connection of the heparin line which came apart.It was reported that the machine, a fresenius 2008k2 machine alarmed, but the alarm was unknown.It was confirmed that the leak was external.There was no defect or damage noted on the bloodlines and no issues were observed during priming.The patient¿s estimated blood loss (ebl) was unknown.The biomed confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted and treatment completed successfully with new supplies.It was unknown if the patient was moved to a new machine or completed treatment on the same machine.The bloodlines were reported to be available to be returned to the manufacturer for evaluation.Additional patient information and treatment details were requested but were unknown.

Manufacturer Narrative

Additional information: d10, h3 plant investigation: the manufacturing plant received representative samples from the fresenius distribution center.The companion samples were visually inspected and was found that the samples are acceptable as no damages or disconnections were found in the heparin line.In addition, the samples were tested in the hemodialysis machine (2008k) for simulated use and worked as intended without any abnormalities during the tested period.To date, the actual samples have not been returned.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, 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.

• 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: 10180963
• MDR Text Key: 198853595
• Report Number: 8030665-2020-00847
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 20AR01114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Device Age: MO
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008K2 MACHINE; FRESENIUS DIALYZER