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 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a combi set blood leak occurred forty-five minutes into a patient¿s hemodialysis (hd) treatment.The blood leak was reportedly coming from the heparin line connection, where it connects to the bloodline tubing.There were no visible defects identified near the location of the leak, and it was confirmed that the heparin line connection was secure prior to treatment initiation.The combi set was reportedly inspected for defects prior to use, and nothing was found.It was unknown if there were any leaks during the priming of the lines.Reportedly, there were no changes to the patient¿s blood flow rate during the treatment.The machine, a fresenius 4008, did not alarm.The patient was utilizing a fresenius optiflux 180nre dialyzer.It was reportedly unknown if the patient¿s blood was returned.After the blood leak was identified, the treatment was halted.The patient reportedly completed their treatment after being re-setup with new supplies.It was unknown if they completed their treatment on the same machine or on a different machine.The patient¿s estimated blood loss (ebl) was approximately 5 ml.It was confirmed that there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The combi set was not available to be returned for a manufacturer evaluation as it was reportedly discarded.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, a photograph of the combi set connected to the machine was provided by the customer.Evidence of a blood leak was apparent in the provided photograph.The photograph shows blood leaking from the red "t" connector on the bloodline, where the heparin line connects.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.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.The reported event was confirmed based on the provided photograph.

• 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: 10480756
• MDR Text Key: 207525343
• Report Number: 8030665-2020-01268
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 20BR01061
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 4008 MACHINE; FRESENIUS OPTIFLUX 180NRE DIALYZER
• Patient Age: 31 YR
• Patient Weight: 55