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

Catalog Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/24/2018

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 clinical manager reported that a blood leak occurred approximately one hour into the patient¿s hemodialysis (hd) treatment.The blood leak was noted to be due to a separation at the junction of the arterial line and the t line in the custom combiset bloodlines.The patient¿s estimated blood loss (ebl) was approximately 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The clinical manager reported that there was no defect or damage observed on the bloodlines prior to treatment and that no issues were noted during prime.It was reported that there were no changes in the patient¿s blood flow rate (bfr) that may have attributed to the separation.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The actual sample was returned to the manufacturer for physical evaluation.A visual inspection was performed on the returned sample.During the visual inspection, a separation between the ¿t¿ connector and the tube was observed.There was no solvent observed in the saline ¿t¿ and tube.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no nonconformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the complaint was able to confirm the reported event.

• 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: 7841794
• MDR Text Key: 119040854
• Report Number: 8030665-2018-01345
• 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: 09/20/2018

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 18CR01242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Device Age: MO
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/19/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; OPTIFLUX 180NRE DIALYZER; FRESENIUS 2008T MACHINE; OPTIFLUX 180NRE DIALYZER
• Patient Age: 70 YR
• Patient Weight: 149