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 03-2722-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/29/2020

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 clinic manager (cm) reported a blood leak that occurred during patient¿s hemodialysis (hd) treatment.The cm stated the heparin line ¿came off of¿ the combi set approximately thirty minutes into the treatment, which caused blood to leak externally.It was initially reported that blood was ¿shooting out of the machine¿.Further clarification was provided on follow up.The cm stated blood was observed leaking out of the bloodlines (heparin line unclamped) which was being fed through the machine¿s blood pump.A fresenius 2008t hd machine was in use, in addition to a fresenius optiflux dialyzer.There were no leaks during the priming phase.The cm stated there were no loose connections noted on the combi set prior to use, and there were no damaged components or defects identified.There were no changes in the patient¿s blood flow rate, nor were there changes or disruptions in the machine¿s pressure.No alarms occurred during the treatment.After the blood leak was noted, the patient¿s treatment was discontinued.The patient¿s estimated blood loss (ebl) was approximately 100 ml.The cm 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 patient was able to complete treatment after being re-setup with new supplies on the same machine.The combi set was not available to be returned for a manufacturer evaluation was it was reportedly discarded.The lot number for the device could not be provided.

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 used combi set was provided by the user facility.The photograph clearly shows that the heparin line had separated from the red "t" connector.The lot number for the combi set bloodline was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combi set bloodlines shipped to this account within the selected time frame.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.The reported event was confirmed based on the provided photographs.

• 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: 10176242
• MDR Text Key: 195807744
• Report Number: 8030665-2020-00843
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

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 Model Number: 03-2722-9
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 80 YR
• Patient Weight: 74