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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a combi set bloodline leak had occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow up with a registered nurse (rn) from the facility who was familiar with the event.The rn reported that immediately at the start of a patient¿s hd treatment, the arterial pressure was noted to be very low.The rn inspected the setup and noticed very little blood coming to the arterial chamber.In addition, the rn could see there were a lot of air bubbles within the chamber.The rn believed air was entering the circuit through a hairline crack somewhere on the combi set.However, the combi set was thoroughly inspected for damage and no visible damage could be found.Additionally, there was no fluid leaking found.The rn paused the treatment multiple times, checked all connections, and clamped and then unclamped the lines during the process.The rn said the same issue continued to occur; visible bubbling was noted within the circuit, which indicated there was an air leak.At one point, the rn even disconnected and then reconnected the connections to the patient¿s catheter.The rn confirmed that all connections were securely fastened.The outcome of this troubleshooting led the rn to believe there was a crack somewhere on the combi set.There were no machine alarms during the event, and there were no leaks during the priming phase.The patient¿s blood was not returned.The rn stated the patient¿s estimated blood loss (ebl) was only 5 ml.The treatment was being performed on a fresenius 2008k2 machine, and an optiflux dialyzer was being used.The patient was re-setup with new supplies on the same machine and was able to complete their treatment without further issue.The rn stated there were no issues with the machine, which has remained in service since this event.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 combi set was not available to be returned for evaluation as it was reportedly discarded.Photos of the combi set connected to the machine were provided for review.Multiple attempts have been made to obtain patient details with no success.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.In the provided photos, the blood level in the arterial chamber is visibly low.This could have caused air bubbles to form in the circuit of the venous line, entering in the monitor line and venous chamber.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.The reported event of blood loss was confirmed in accordance with the photos received, however, a cause for the reported failure could not be determined.

Event Description

It was reported that a combi set bloodline leak had occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow up with a registered nurse (rn) from the facility who was familiar with the event.The rn reported that immediately at the start of a patient¿s hd treatment, the arterial pressure was noted to be very low.The rn inspected the setup and noticed very little blood coming to the arterial chamber.In addition, the rn could see there were a lot of air bubbles within the chamber.The rn believed air was entering the circuit through a hairline crack somewhere on the combi set.However, the combi set was thoroughly inspected for damage and no visible damage could be found.Additionally, there was no fluid leaking found.The rn paused the treatment multiple times, checked all connections, and clamped and then unclamped the lines during the process.The rn said the same issue continued to occur; visible bubbling was noted within the circuit, which indicated there was an air leak.At one point, the rn even disconnected and then reconnected the connections to the patient¿s catheter.The rn confirmed that all connections were securely fastened.The outcome of this troubleshooting led the rn to believe there was a crack somewhere on the combi set.There were no machine alarms during the event, and there were no leaks during the priming phase.The patient¿s blood was not returned.The rn stated the patient¿s estimated blood loss (ebl) was only 5 ml.The treatment was being performed on a fresenius 2008k2 machine, and an optiflux dialyzer was being used.The patient was re-setup with new supplies on the same machine and was able to complete their treatment without further issue.The rn stated there were no issues with the machine, which has remained in service since this event.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 combi set was not available to be returned for evaluation as it was reportedly discarded.Photos of the combi set connected to the machine were provided for review.Multiple attempts have been made to obtain patient details with no success.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12749374
• MDR Text Key: 280095626
• Report Number: 8030665-2021-01683
• 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: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03-2722-9
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 21JR01123
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• 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
• Treatment: FRESENIUS 2008K2 MACHINE; FRESENIUS 2008K2 MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER