MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number	03-2794-0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the complaint sample was not available for manufacturer evaluation.Additionally, there were no companion samples available at the distribution centers.The entire lot has been sold and distributed.However, photos of the defective device were provided for review.In the photos, it could be confirmed there was a leak at the twister component.However, there were no cracks or broken components visible.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.A device history record (dhr) review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.In addition, there was no associated rework related to this failure during the assembly of the lot.The lot met all specifications for release.Based on the provided information, the reported complaint was confirmed.
Event or Problem Description
A user facility biomedical technician reported that the access flow twister on a combi set bloodline snapped while in use resulting in blood loss.Additional information was provided upon follow-up with the facility administrator (fa) from the unit.The fa reported that access flow testing was being performed when the product failure occurred.The incident occurred within the first thirty minutes of hemodialysis (hd) treatment.When the staff twisted the twister component, it snapped and blood started leaking out.There were no machine alarms.There were no known changes or disruptions in pressure that could have caused the failure.Once the leak was identified, the treatment was immediately stopped, and the lines were clamped.The patient's blood was not returned; estimated blood loss (ebl) due to the event was 250 ml.The fa 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.The combi set was not available to be returned for evaluation as it was reportedly discarded.Photos of the defective component were provided for review.
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 biomedical technician reported that the access flow twister on a combi set bloodline snapped while in use resulting in blood loss.Additional information was provided upon follow-up with the facility administrator (fa) from the unit.The fa reported that access flow testing was being performed when the product failure occurred.The incident occurred within the first thirty minutes of hemodialysis (hd) treatment.When the staff twisted the twister component, it snapped and blood started leaking out.There were no machine alarms.There were no known changes or disruptions in pressure that could have caused the failure.Once the leak was identified, the treatment was immediately stopped, and the lines were clamped.The patient's blood was not returned; estimated blood loss (ebl) due to the event was 250 ml.The fa 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.The combi set was not available to be returned for evaluation as it was reportedly discarded.Photos of the defective component were provided for review.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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: 20811072
• Report Number: 0008030665-2024-01150
• Device Sequence Number: 9474674
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 03-2794-0
• Device Lot Number: 24HR01145
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2024
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 95 KG