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

Catalog Number	03-2622-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
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 biomedical technician (bmt) reported a line occluded during a patient's hemodialysis (hd) treatment.It did not allow liquid to flow at the junction of the segment and heparin line.The staff immediately replaced the product with the new supplies.The estimated blood loss was unknown.Additional information was requested but was not received to date.
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 biomedical technician (bmt) reported a line occluded during a patient's hemodialysis (hd) treatment.It did not allow liquid to flow at the junction of the segment and heparin line.The staff immediately replaced the product with the new supplies.Upon follow-up, the facility reported the customer confirmed that the blood line did not present with an occlusion, and a blood leak was observed one minute before ending the patient¿s hemodialysis (hd) session.There was no damage was noted on the comibset.The machine, a fresenius 4008s v10 clasica, did not alarm as the blood leak was external.The exact location of the leak was not specified.It was unknown if a fresenius dialyzer was being used at the time of the event.There was no blood lost, and the customer stated that they only wanted to report that the heparin line was occluded.It was reported due to the external leak occurring at the end of the treatment, it was not necessary to change the supplies, and the patient concluded the treatment with the same supplies.The estimated blood loss (ebl) to the patient was 2ml.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 sample was discarded was no longer available to be returned for manufacturer evaluation.
Event or Problem Description
A user facility biomedical technician (bmt) reported a line occluded during a patient's hemodialysis (hd) treatment.It did not allow liquid to flow at the junction of the segment and heparin line.The staff immediately replaced the product with the new supplies.Upon follow-up, the facility reported the customer confirmed that the blood line did not present with an occlusion, and a blood leak was observed one minute before ending the patient¿s hemodialysis (hd) session.There was no damage was noted on the comibset.The machine, a fresenius 4008s v10 clasica, did not alarm as the blood leak was external.The exact location of the leak was not specified.It was unknown if a fresenius dialyzer was being used at the time of the event.There was no blood lost, and the customer stated that they only wanted to report that the heparin line was occluded.It was reported due to the external leak occurring at the end of the treatment, it was not necessary to change the supplies, and the patient concluded the treatment with the same supplies.The estimated blood loss (ebl) to the patient was 2ml.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 sample was discarded was no longer available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Additional information: a1, a2, a3, a4, b5.

• Brand Name: 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: 18347934
• Report Number: 0008030665-2023-01147
• Device Sequence Number: 5600751
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2024

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: Other
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 03-2622-3
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 01/31/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/04/2024; 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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 4008S MACHINE; FRESENIUS 4008S MACHINE; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 48 KG