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 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and a physical evaluation of the device could not be performed.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.A product history review 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.

Event Description

A clinical care coordinator reported that a fresenius combi set disconnected during a patient¿s hemodialysis (hd) treatment, resulting in blood loss.The heparin line on the arterial end of the bloodline reportedly disconnected from the heparin pump.It was reported that this occurred approximately halfway through the patient¿s treatment.A small amount of blood was observed leaking from the bloodline due to the disconnection.The patient¿s estimated blood loss (ebl) was reported to be less than 5 ml.The operator immediately clamped off the lines and returned the patient¿s blood.The machine, a fresenius 2008t, did not alarm.There were no visible defects on the combi set, and nothing out of the ordinary was noticed during the prime.The reporter 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 set up with new supplies on the same machine.The combi set was discarded after the incident and therefore was not available to be sent back for a physical evaluation.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9536391
• MDR Text Key: 189065192
• Report Number: 8030665-2019-01964
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 19JR01164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1