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

Model Number	03-2742-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility clinic manager (cm) reported an arc-shaped tear/gouge of approximately 5/16" was noted on the blood tubing's pump segment during a patient's hemodialysis (hd) treatment.The machine was set-up by an experienced former patient care technician (pct) now registered nurse (rn).Nothing sharp or abnormal was noted in pump area.The estimated blood loss (ebl) was unknown.Photos were provided.The sample was no longer available to be returned for evaluation.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.
Additional Manufacturer Narrative
Additional information: a1, a2, a3, a4, b5 correction: d10 concomitant products.
Event or Problem Description
A user facility clinic manager (cm) reported an arc-shaped tear/gouge of approximately 5/16" was noted on the blood tubing's pump segment during a patient's hemodialysis (hd) treatment.The machine was set-up by an experienced former patient care technician (pct) now registered nurse (rn).Nothing sharp or abnormal was noted in pump area.Upon follow-up, the cm stated a blood leak occurred right from the start and was sucking air.The blood leak was observed at the blood pump segment of the tubing.The machine, a 2008t, alarmed with an air alarm and the machine was not removed from service following the event.A fresenius dialyzer was being used during the incident.Blood test strips were not required or used.The patient's blood was not returned and the estimated blood loss (ebl) was unknown.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 patient did complete their treatment on the same machine following the event after setting up with new supplies.The combi set was not available to be returned for evaluation.Photos were provided.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, a photo of the alleged malfunction was received from the customer.According with the photo received, it can be observed a tear in the pump tubing to the adapter.The alleged failure mode was confirmed; a leak from the tubing.This kind of damage (tear) could be caused due to an incorrect handling of the product either during the manufacturing process or treatment set up.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.All the applicable in-process and final inspection tests were found with acceptable results.
Event or Problem Description
A user facility clinic manager (cm) reported an arc-shaped tear/gouge of approximately 5/16" was noted on the blood tubing's pump segment during a patient's hemodialysis (hd) treatment.The machine was set-up by an experienced former patient care technician (pct) now registered nurse (rn).Nothing sharp or abnormal was noted in pump area.Upon follow-up, the cm stated a blood leak occurred right from the start and was sucking air.The blood leak was observed at the blood pump segment of the tubing.The machine, a 2008t, alarmed with an air alarm and the machine was not removed from service following the event.A fresenius dialyzer was being used during the incident.Blood test strips were not required or used.The patient's blood was not returned and the estimated blood loss (ebl) was unknown.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 patient did complete their treatment on the same machine following the event after setting up with new supplies.The combi set was not available to be returned for evaluation.Photos were provided.

• 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: 16858375
• Report Number: 0008030665-2023-00413
• Device Sequence Number: 6564800
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/30/2023

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: 11/30/2025
• Device Model Number: 03-2742-9
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 22PR01182
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 05/03/2023; 05/29/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/03/2023; 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 69 KG