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 01/01/2020

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 in (b)(6) reported a blood leak that occurred during a patient¿s hemodialysis (hd) treatment.The blood leak occurred at the bloodline connector.It was reported the blood leak occurred sometime in 2020, however an exact date was not provided.It was unknown how long into the patient¿s treatment the blood leak occurred and if there were any connection issues, defect, or damage noticed on the bloodline.Additionally, it was unknown if there were any patient symptoms, injuries, adverse events, or medical intervention required, or if the patient was able to complete treatment.Patient information, including estimated blood loss, was unknown.The complaint device was not available to be returned to the manufacturer for physical evaluation.Additional information regarding the event was requested, however was not provided.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.As no lot number was provided for this complaint, a product delivery history search (for the 2020 year) was requested.The pharmacovigilance specialist for fmc mexico provided the delivery history search.Eight lots were found to have been delivered in this time period.The entire set of lots have been sold and distributed.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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: 9950468
• MDR Text Key: 188332849
• Report Number: 8030665-2020-00487
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 4008 V 10 MACHINE; FRESENIUS DIALYZER