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 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility clinic manager (cm) reported a combi set blood leak that occurred during a patient¿s hemodialysis (hd) treatment.Per the cm, the heparin line became separated from the combi set approximately four minutes into the treatment, which resulted in blood loss.The machine, a fresenius 2008t, did not alarm.A fresenius optiflux dialyzer was also being used.There were no leaks during pre-treatment priming, and no loose connections were noted prior to treatment initiation.The cm stated there were no defects identified on the combi set before it was used.The patient¿s estimated blood loss (ebl) was reportedly less than 50 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 their treatment on a different machine.The combi set was not available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, photographs of the bloodline connected to the machine were provided by the customer.Evidence of the blood leak was apparent in the provided photographs.The photographs show that the leak was coming from the heparin line which had separated from the red "t" connector.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.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: 10176335
• MDR Text Key: 196794299
• Report Number: 8030665-2020-00844
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 03-2722-9
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 20BR01240
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 39 YR
• Patient Weight: 82