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	08/02/2024
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 clinic manager (cm) reported a combiset bloodline broke at the venous line at the top of twist port, causing a blood leak to occur.A photo was provided for the investigation.Upon follow-up, the cm stated stated a blood leak occurred from a breakage in the white twist port connected to the venous line approximately twenty minutes after initiation of treatment.The machine, a 2008t, alarmed with an an arterial blood leak alert.Per cm it was unknown what caused the port to break off.A fresenius 2008t hemodialysis machine and fresenius dialyzer were being used during the incident.Blood test strips were not required or used.The patient's blood was returned from the arterial side of the set and the estimated blood loss (ebl) was 300ml.Immediately following the event, the treatment was halted and the patient was re-setup with a new dialyzer and bloodlines, and completed their treatment on the same machine.The cm 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 combiset was discarded and was no longer available to be returned for evaluation.A photo was provided for the investigation.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.However, a photo of the alleged malfunction was received.According to the photo received, it could be observed that the twister port is broken.The sample is not available for physical analysis.The alleged failure mode was confirmed with the photo received.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The complaint is confirmed.
Event or Problem Description
A user facility clinic manager (cm) reported a combiset bloodline broke at the venous line at the top of twist port, causing a blood leak to occur.A photo was provided for the investigation.Upon follow-up, the cm stated stated a blood leak occurred from a breakage in the white twist port connected to the venous line approximately twenty minutes after initiation of treatment.The machine, a 2008t, alarmed with an an arterial blood leak alert.Per cm it was unknown what caused the port to break off.A fresenius 2008t hemodialysis machine and fresenius dialyzer were being used during the incident.Blood test strips were not required or used.The patient's blood was returned from the arterial side of the set and the estimated blood loss (ebl) was 300ml.Immediately following the event, the treatment was halted and the patient was re-setup with a new dialyzer and bloodlines, and completed their treatment on the same machine.The cm 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 combiset was discarded and was no longer available to be returned for evaluation.A photo was provided for the investigation.

• 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: 19964234
• Report Number: 0008030665-2024-00697
• Device Sequence Number: 7064799
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 24CR01046
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2024
• 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 BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 60 KG