MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LOW VOLUME PRE-PUMP BLOODLINE (12/CS); SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	03-2692-6
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility administrator (fa) reported to fresenius that the arterial chamber on the bloodline set filled without opening the clamp and the heparin line occluded and prevented the passage of solution during the patient's hemodialysis (hd) treatment.The reported issue was resolved by replacing the supplies.Additional information was obtained during follow-up.Treatment was performed on a 4008s machine.It was not reported how far into treatment the failure occurred.There was no serious injury or required medical intervention.The patient's estimated blood loss (ebl) was approximately 50 ml.Treatment was restarted on the same machine and completed successfully with new supplies.No loose connections were identified.No defect or damage was noted.The sample was not reported to be available to be returned to the manufacturer for physical evaluation.
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 facility administrator (fa) reported to fresenius that the arterial chamber on the bloodline set filled without opening the clamp and the heparin line occluded and prevented the passage of solution during the patient's hemodialysis (hd) treatment.The reported issue was resolved by replacing the supplies.Additional information was obtained during follow-up.Treatment was performed on a 4008s machine.It was not reported how far into treatment the failure occurred.There was no serious injury or required medical intervention.The patient's estimated blood loss (ebl) was approximately 50 ml.Treatment was restarted on the same machine and completed successfully with new supplies.No loose connections were identified.No defect or damage was noted.The sample was not reported to be 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.

• Brand Name: LOW VOLUME PRE-PUMP BLOODLINE (12/CS)
• 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: 18588972
• Report Number: 0008030665-2024-00095
• Device Sequence Number: 7049888
• Product Code: FJK
• UDI-Device Identifier: 00840861100262
• UDI-Public: 00840861100262
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K001107
• 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: Administrator/Supervisor
• Type of Report: Initial,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: 08/31/2025
• Device Catalogue Number: 03-2692-6
• Device Lot Number: 22KR01002
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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 4008S MACHINE; FRESENIUS 4008S MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 20 KG