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

Model Number 03-2622-3

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/27/2020

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 buyer for a hemodialysis (hd) user facility reported to fresenius customer service (cs) that a combi set blood leak occurred during a patient's hd treatment.The buyer was inquiring about replacing their unused combi sets from this lot.Few details were obtained via follow up with a nurse from the user facility.The nurse confirmed there was a bloodline blood leak, but could not provide specific event details.The nurse was unable to recall the date of the event, or the patient involved.It was believed that the leak was coming from the portion of the bloodline tubing close to where the device is connected to the patient.Reportedly, there were no adverse effects experienced by the patient and medical intervention was not required as a result of the event.The nurse stated the patient's treatment was able to be completed after they were re-setup with new supplies.The device was discarded immediately after use and was not available to be returned for evaluation.At this time, no further information has been provided.

Manufacturer Narrative

Plant investigation: six cases of companion samples from lot 20ar01099 were returned to the manufacturing plant for evaluation.During the gross visual examination of the returned samples, no irregularities were identified.The arterial and venous patient connectors were closely inspected, and no damages were found.The male conical fitting of the venous and arterial patient connectors were inspected, and dimensionally, they were found to be within tolerance.Functional testing was then performed.One of the companion samples was used in a simulated treatment on a 2008k hemodialysis (hd) machine.For the simulation, the combi set sample was connected to an optiflux f250nr dialyzer filter.During the simulated use test, no leaks were observed at the patient connectors.No air bubbles inside the system were noted, no alarms occurred, and there was no level variation in the venous or arterial chambers.The simulated treatment was completed successfully without complications.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.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The combi set sample performed as designed and an associated cause could not be determined.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation 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.

Manufacturer Narrative

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

Event Description

The buyer for a hemodialysis (hd) user facility reported to fresenius customer service (cs) that a combi set blood leak occurred during a patient's hd treatment.The buyer was inquiring about replacing their unused combi sets from this lot.Few details were obtained via follow up with a nurse from the user facility.The nurse confirmed there was a bloodline blood leak, but could not provide specific event details.The device was discarded immediately after use and was not available to be returned for evaluation.Additional details were later provided by the nurse from the user facility.The nurse confirmed blood was observed leaking from the tubing of the combi set, below where the bloodline connects to the patient.There were no reports of visible damage (e.G.A pinhole or cut) at the site of the leak.There were no machine alarms.The patient was dialyzing on a fresenius 2008t machine and was utilizing an optiflux f250nre dialyzer.The patient¿s estimated blood loss (ebl) was minimal.The nurse stated the ebl was approximately 15 ml.It was 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.

• Brand Name: 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: 10268047
• MDR Text Key: 200235024
• Report Number: 8030665-2020-00972
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• 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,Followup,Followup
• Report Date: 11/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 20AR01099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Device Age: MO
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX F250NRE DIALYZER
• Patient Age: 47 YR
• Patient Weight: 98