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

Model Number	03-2622-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
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
It was reported to fresenius that a crack was identified in the venous chamber of the combiset bloodlines during a patient's hemodialysis (hd) treatment.There was blood loss as a result of the reported issue.The patient's estimated blood loss (ebl) was not provided.There was no adverse event or required medical intervention reported.The patient continued treatment after the bloodlines were replaced.The sample is not available to be returned to the manufacturer for physical evaluation.Additional information was requested however a response has not been received.
Event or Problem Description
It was reported to fresenius that a crack was identified in the venous chamber of the combiset bloodlines during a patient's hemodialysis (hd) treatment.There was blood loss as a result of the reported issue.Additional information was obtained during follow-up.The reported event occurred approximately 10 minutes after treatment initiation.The reported issue was visually observed.There was no serious injury or required medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) was not provided.The blood within the circuitry was returned.The patient completed treatment on the same machine with new supplies.The sample has been discarded and is not available to be returned to the manufacturer for physical evaluation.
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
It was reported to fresenius that a crack was identified in the venous chamber of the combiset bloodlines during a patient's hemodialysis (hd) treatment.There was blood loss as a result of the reported issue.Additional information was obtained during follow-up.The reported event occurred approximately 10 minutes after treatment initiation.The reported issue was visually observed.There was no serious injury or required medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) was not provided.The blood within the circuitry was returned.The patient completed treatment on the same machine with new supplies.The sample has been discarded and is not available to be returned to the manufacturer for physical evaluation.

• 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: 16702043
• Report Number: 0008030665-2023-00344
• Device Sequence Number: 17585706
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2023

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: 07/31/2025
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 22JR01016
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 04/28/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 04/27/2023; 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2022
• 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
• Patient Sex: Male