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	03-2742-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility clinical manager (cm) reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.Blood was noted to be leaking onto the patient¿s clothing.After troubleshooting the source of the leak, a crack was noted on the ¿connecting hub¿ of the combi set.Additional details were provided upon follow-up with a registered nurse (rn) from the facility.The rn confirmed that blood was leaking out of the connecting hub at the end of the venous line, where it connects to the needle.The rn indicated that the treatment had started less than thirty minutes prior to identifying the leak.There were no machine alarms that occurred, and no leaks were noticed during the prime.There were no obvious signs of any defects on the combi set when the circuit was initially set up.However, upon close inspection of the device after the leak occurred, a crack was observed on the connector.The crack was confirmed to be located on a component of the combi set.The treatment was immediately halted once the leak was identified.Blood was returned from the arterial side of the set up only.The patient¿s estimated blood loss (ebl) due to the event was 150 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 completed their treatment after being re-setup with new supplies on a different machine.The combi set was not available to be sent back for manufacturer evaluation as it was reportedly discarded.
Additional 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.
Event or Problem Description
A user facility clinical manager (cm) reported that a combi set blood leak occurred during a patient¿s hemodialysis (hd) treatment.Blood was noted to be leaking onto the patient¿s clothing.After troubleshooting the source of the leak, a crack was noted on the ¿connecting hub¿ of the combi set.Additional details were provided upon follow-up with a registered nurse (rn) from the facility.The rn confirmed that blood was leaking out of the connecting hub at the end of the venous line, where it connects to the needle.The rn indicated that the treatment had started less than thirty minutes prior to identifying the leak.There were no machine alarms that occurred, and no leaks were noticed during the prime.There were no obvious signs of any defects on the combi set when the circuit was initially set up.However, upon close inspection of the device after the leak occurred, a crack was observed on the connector.The crack was confirmed to be located on a component of the combi set.The treatment was immediately halted once the leak was identified.Blood was returned from the arterial side of the set up only.The patient¿s estimated blood loss (ebl) due to the event was 150 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 completed their treatment after being re-setup with new supplies on a different machine.The combi set was not available to be sent back for manufacturer evaluation as it was reportedly discarded.

• Brand Name: CUSTOM COMBI SET
• Common Device Name: 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; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 19899169
• Report Number: 0008030665-2024-00682
• Device Sequence Number: 20472278
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K962081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 24CR01219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG