MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 5008X STANDARD HDF BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	03-5100-7C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 5008x hemodialysis (hd) machine displayed a "blood leak detected" alarm during a patient's hd treatment.A fresenius field service technician (fst) was called onsite and verified that the blood leak detector was functioning correctly.Machine functional tests were completed and passed onsite after repair.Follow up with the charge nurse (cn) revealed that a fresenius 5008x bloodline leaked twenty-five minutes into a patient's hd treatment.The machine, a fresenius 5008x hemodialysis (hd) machine alarmed appropriately with a ¿blood leak detected" alarm.Blood leak test strips were not used.A fresenius dialyzer was also in use.The leak was observed from the connection at the bottom of the venous chamber of the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 320ml.There was no patient injury or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: upon further review, it was determined that the event reported on mfr 8030665-2025-00122 was previously captured and reported in mfr 8030665-2025-00124.There will be no further updates on 8030665-2025-00122.
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 5008x hemodialysis (hd) machine displayed a "blood leak detected" alarm during a patient's hd treatment.A fresenius field service technician (fst) was called onsite and verified that the blood leak detector was functioning correctly.Machine functional tests were completed and passed onsite after repair.Follow up with the charge nurse (cn) revealed that a fresenius 5008x bloodline leaked twenty-five minutes into a patient's hd treatment.The machine, a fresenius 5008x hemodialysis (hd) machine alarmed appropriately with a "blood leak detected" alarm.Blood leak test strips were not used.A fresenius dialyzer was also in use.The leak was observed from the connection at the bottom of the venous chamber of the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 320 ml.There was no patient injury or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

• Brand Name: 5008X STANDARD HDF BLOODLINE
• 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: 21168355
• Report Number: 0008030665-2025-00122
• Device Sequence Number: 11846142
• Product Code: FJK
• UDI-Device Identifier: 00840861102365
• UDI-Public: 00840861102365
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231534
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: 09/30/2025
• Device Catalogue Number: 03-5100-7C
• Device Lot Number: 24LR01214
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2024
• 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 DIALYZER; FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 66 KG