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 01/01/2019

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 that they observed the hemodialysis (hd) dialyzer and bloodline presented blood coagulation sometime in 2019, however an exact date was not provided.The customer stated that the incident occurred because the hd machine, a fresenius 4008 v10, presented some unspecified problems.The customer was unable to provide further information regarding the incidents.Upon follow up, it was confirmed that the dialyzers and bloodlines were used during the same treatment.It could not be confirmed if the events occurred only as a result of a machine issue and not an issue with the dialyzer or bloodline used.Specific details on hd machine issues were not reported nor any details regarding a resolution or service performed on the device.It is unknown if there were any patient injuries, adverse events, or medical intervention required as a result of the event.No further details were provided.Patient information, including estimated blood loss, was unknown.The complaint devices were not available to be returned to the manufacturer for physical evaluation.Additional information regarding the event was requested, however was not provided.

Manufacturer Narrative

Corrected information: h6 - conclusion: c139471 (inadvertently selected wrong code).

Event Description

Additional information was provided by the user facility.It was confirmed that the machines had a failure, and the response time of the machine was greater than usual, which led to the clotting of the bloodline and dialyzer.The event date and product information was not available.The machine failure was documented in a log, however the log was unavailable.

Manufacturer Narrative

Additional information: b5 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 2019 year as well as three months prior to any product delivered in (b)(6) 2019) was requested.The pharmacovigilance specialist for fmc mexico provided the delivery history search and mentioned the customer had only begun using the product in (b)(6) 2019.11 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-conformances 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: 9941902
• MDR Text Key: 188078667
• Report Number: 8030665-2020-00416
• 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,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 4008 V 10 MACHINE; FRESENIUS DIALYZER