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 faculty administrator (fa) reported that the bloodline was leaking at the base of the heparin line near the blood pump.Upon follow-up, the fa stated that the leaking was external.It was reported the patient's estimated blood loss (ebl) was approximately 59 ml.It was confirmed that there was no patient injury, adverse event, or medical intervention as a result of the reported event.The bloodlines were replaced and the patient completed treatment successfully on the same machine.The bloodline used during treatment is not available to be returned to the manufacturer for evaluation because it was discarded.However, a video of the reported issue was provided.Additional patient and treatment details were requested but were unavailable.

Manufacturer Narrative

Plant investigation: representative samples were returned to the manufacturing plant for investigation.The companion samples were visually inspected and were found acceptable; no separations found from the heparin line to red ¿t¿ connector.In addition, the companion sample were tested in the cycler machine and no separation, disconnection or leaks occurred during tested period from the heparin line to the red "t" connector.The companion samples tested worked as intended without any abnormalities during the tested period.However, based on the video of the reported issue from the customer, the reported issue could be confirmed as a leak was shown in the video.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.

• 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: 10155373
• MDR Text Key: 195232818
• Report Number: 8030665-2020-00808
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• 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: 20BR01119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• 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 2008K MACHINE