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 03-2742-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/30/2020

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 registered nurse (rn) reported that a combi set blood leak occurred immediately at the beginning of a patient¿s hemodialysis (hd) treatment.Upon follow up, it was reported that a faint hissing noise was heard, which sounded ¿like air leaking out of a flat tire¿.In addition, blood droplets were observed ¿bubbling up¿ from the top of the venous chamber, where the transducer line connects.The leak was reportedly coming from this connection.No leaking occurred during the priming, and all connections were reportedly tightened properly.The rn stated there were no machine alarms.The patient was dialyzing on a fresenius 2008t hd machine, and was utilizing an optiflux dialyzer.After the blood leak was noted, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was approximately 250 ml.The rn 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 treatment after being re-setup with new supplies on the same machine.The combi set bloodlines were discarded after the event, and therefore, the lot number for the device could not be provided.No sample available for evaluation.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combi set bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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.

• 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: 10440913
• MDR Text Key: 205516012
• Report Number: 8030665-2020-01199
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• 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: 08/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03-2742-9
• Device Catalogue Number: 03-2742-9
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 83 YR
• Patient Weight: 106