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 08/28/2020

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 fresenius dialyzer and combi set clotted approximately one-hundred and four minutes into a patient¿s hemodialysis (hd) treatment.The treatment was interrupted with arterial and venous pressure alarms, in addition to a transmembrane pressure (tmp) alarm.The nursing staff inspected the system, and noted the blood coagulation.The clotting was reportedly, visible on the dialyzer membranes.Upon follow-up, it was confirmed that both the dialyzer and combi set were inspected for defects prior to use, and no defects were identified.It was unknown if there were any changes to the patient¿s blood flow rate during the treatment.The patient was dialyzing on a fresenius 4008s hd machine.It was unknown if the patient¿s blood was returned, and therefore, the patient¿s estimated blood loss (ebl) was also unknown.The patient completed their treatment after being re-setup with new supplies on the same machine.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The dialyzer and combi set were not available to be returned for physical evaluation as they were reportedly discarded.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.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.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: 10544683
• MDR Text Key: 207302418
• Report Number: 8030665-2020-01344
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 20ER01059
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 4008S MACHINE; FRESENIUS OPTIFLUX 180NRE DIALYZER; FRESENIUS 4008S MACHINE; FRESENIUS OPTIFLUX 180NRE DIALYZER
• Patient Age: 65 YR
• Patient Weight: 60