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 09/12/2020

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 an external blood leak occurred approximately 30 minutes into a patient¿s hemodialysis (hd) treatment.The blood leak was external and visually observed.Drops of blood were found on the machine by the nursing staff, and upon inspection the heparin line was found to be separated from the blood line.The machine used for treatment, a 4008's machine, did not alarm.There were no reported loose connections and no issues were noted during priming of the lines.The patient¿s estimated blood loss (ebl) was approximately 5 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was able to complete treatment by continuing treatment on the same machine with different supplies.No changes were reported to the patients blood flow rate (bfr).The complaint device was discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, a photograph was received from the customer confirming that the heparin line separated from the "t" connector.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during assembly that could be associated with the reported event.The entire lot has been sold and distributed.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.As a physical evaluation 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: 10602485
• MDR Text Key: 209196768
• Report Number: 8030665-2020-01429
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 20DR01058
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 4008S MACHINE; FRESENIUS DIALYZER
• Patient Age: 80 YR
• Patient Weight: 72