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 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The clinical nurse manager (cnm) from a hemodialysis (hd) user facility reported that a combi set blood leak occurred at the start of a patient¿s hd treatment.The patient¿s blood flow rate was increased from 200 ml/min to 350 ml/min, and immediately afterwards, the patient care technician (pct) noticed a drip of blood coming from the heparin line (where it connects to the arterial line).The pct went to get gauze to clean up the blood, and by the time they returned, blood had ¿leaked everywhere¿.The heparin line had completely separated from the arterial line.The cnm reported that the increase in pressure ¿pushed out¿ the heparin line, causing the separation.There were no reported alarms, and there were no leaks noted during the priming of the lines.All connections were confirmed to be intact during setup.After the heparin line separated from the bloodline, the treatment was paused and the patient¿s blood was returned.The patient¿s estimated blood loss (ebl) was reported to be 20 ml.The cnm 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 completed their treatment after being re-setup with new supplies on the same machine.The combi set was reportedly available to be returned for a manufacturer evaluation.

Manufacturer Narrative

Additional information: d10, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.A visual inspection revealed that the heparin line had separated from the red ¿t¿ connector on the bloodline.No solvent application was found on the red ¿t¿ connector port or on the end of the heparin line tubing that separated from the connector.A dimensional inspection was performed on the returned sample (which included the red ¿t¿ connector and heparin line), and the results were found to be within tolerance.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.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.Upon completion of the evaluation, the reported event was confirmed.

• 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: 10717632
• MDR Text Key: 212984339
• Report Number: 8030665-2020-01549
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

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 Expiration Date: 06/30/2023
• Device Model Number: 03-2722-9
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 20HR01168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Device Age: MO
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 84 YR
• Patient Weight: 88