MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number CUSTOM COMBI SET

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  malfunction  

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.

Event Description

A user facility biomedical technician (bmt) reported a blood leak that occurred with 2 hours left of the patient¿s hemodialysis (hd) treatment.The machine alarmed with an air detected alarm prior to the leak.The blood leak was visually observed at the tubing of the custom combi set.There was no damage noticed on the custom combi set.The patient¿s estimated blood loss (ebl) was approximately 240cc.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with different supplies.The complaint devices were discarded and are not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the actual devices were returned to the manufacturer for physical evaluation.All the samples were visually inspected and were found within specifications, the arterial and venous lines were closely reviewed and no damages were observed.A functional test was performed to the companion samples on the hemodialysis machine 2008t for simulated use and all samples worked as intended without any abnormalities during the testing period; no leaks were observed.During the evaluation of the samples, the alleged failure stated in the complaint was not confirmed.The device history record (dhr) of this product was reviewed and no nonconformance reports or other abnormalities during the assembly of this lot were found.The product involved was released meeting specifications.

• Brand Name: CUSTOM 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: 9117922
• MDR Text Key: 160019933
• Report Number: 8030665-2019-01515
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: CUSTOM COMBI SET
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 19JR01040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Device Age: MO
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER
• Patient Age: 62 YR
• Patient Weight: 67