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	10/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility clinic manager (cm) reported blood was noted coming from the blood pump segment of the bloodline.After inspecting the bloodline after it was removed from the machine, it was noted that a small slit was along side of the inside of the line.The estimated blood loss was unknown.Additional information was requested but was not received to date.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility clinic manager (cm) reported blood was noted coming from the blood pump segment of the bloodline.After inspecting the bloodline after it was removed from the machine, it was noted that a small slit was along side of the inside of the line.Upon follow-up, the cm stated the blood leak occurred one hour and fifteen minutes after initiation of treatment.The cm stated blood was seen dripping down from the blood pump segment of the bloodline.The machine, a 2008t, was removed from service following the event.The cm stated there was no issue with the dialysis machine and the machine was pulled from service and remained sequestered.A fresenius dialyzer was also used during the event.The patient's blood was not returned and the estimated blood loss (ebl) was 250ml.It was noted the bloodline appeared damaged.The staff did not report any damage prior to setup with the bloodline.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient was restarted on a different machine and treatment completed successfully with new supplies.The sample is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to date 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.
Additional Manufacturer Narrative
Additional information: a1, a2, a3, a4, b5, d9, h3.
Event or Problem Description
A user facility clinic manager (cm) reported blood was noted coming from the blood pump segment of the bloodline.After inspecting the bloodline after it was removed from the machine, it was noted that a small slit was along side of the inside of the line.Upon follow-up, the cm stated the blood leak occurred one hour and fifteen minutes after initiation of treatment.The cm stated blood was seen dripping down from the blood pump segment of the bloodline.The machine, a 2008t, was removed from service following the event.The cm stated there was no issue with the dialysis machine and the machine was pulled from service and remained sequestered.A fresenius dialyzer was also used during the event.The patient's blood was not returned and the estimated blood loss (ebl) was 250ml.It was noted the bloodline appeared damaged.The staff did not report any damage prior to setup with the bloodline.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient was restarted on a different machine and treatment completed successfully with new supplies.The sample is available to be returned to the manufacturer for physical evaluation.

• 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: 18056278
• Report Number: 0008030665-2023-01000
• Device Sequence Number: 14931067
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2023

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 23HR01255
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 11/17/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/08/2023; 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2023
• 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 DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 61 KG