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	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported a combi set blood leak that occurred upon the start of a patient¿s hemodialysis (hd) treatment.It was reported that the combi set had a manufacturing defect on the transducer of the arterial line.The transducer was reported to be ill fitting and had a crack which caused air to enter the circuit.However, upon follow-up it could not be confirmed if there was a visible crack on the transducer.It was confirmed that there were no leaks during the priming phase.It was also confirmed that the device was not dropped prior to use.The patient¿s estimated blood loss (ebl) due to the leak was 200 ml.The machine, a 4008s, did not produce any alarms.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 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 manufacturer evaluation as it was reportedly discarded.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, a video and photos were provided for review.In the content, it could be observed that the transducer protector was broken and leaking.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.Based on the provided content (video and photos), the alleged failure mode was able to be confirmed.
Event or Problem Description
A user facility reported a combi set blood leak that occurred upon the start of a patient¿s hemodialysis (hd) treatment.It was reported that the combi set had a manufacturing defect on the transducer of the arterial line.The transducer was reported to be ill fitting and had a crack which caused air to enter the circuit.However, upon follow-up it could not be confirmed if there was a visible crack on the transducer.It was confirmed that there were no leaks during the priming phase.It was also confirmed that the device was not dropped prior to use.The patient¿s estimated blood loss (ebl) due to the leak was 200 ml.The machine, a 4008s, did not produce any alarms.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 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 manufacturer evaluation as it was reportedly discarded.
Additional Manufacturer Narrative
Additional information: h6, the findings and conclusion codes have been updated in the investigation.
Event or Problem Description
A user facility reported a combi set blood leak that occurred upon the start of a patient¿s hemodialysis (hd) treatment.It was reported that the combi set had a manufacturing defect on the transducer of the arterial line.The transducer was reported to be ill fitting and had a crack which caused air to enter the circuit.However, upon follow-up it could not be confirmed if there was a visible crack on the transducer.It was confirmed that there were no leaks during the priming phase.It was also confirmed that the device was not dropped prior to use.The patient¿s estimated blood loss (ebl) due to the leak was 200 ml.The machine, a 4008s, did not produce any alarms.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 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 manufacturer evaluation as it was reportedly discarded.

• 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: 17834671
• Report Number: 0008030665-2023-00905
• Device Sequence Number: 7456878
• 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): 02/13/2024

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 23CR01038
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 02/13/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/27/2023; 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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.; FRESENIUS 4008S.; FRESENIUS 4008S.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 68 KG