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	03-5100-7
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility charge nurse (cn) reported that a 5008x bloodline leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak occurred mid-treatment and was reported to be coming from the connection between the venous chamber and the line that returns to the patient.There were no other known issues leading up to the event, and there were no leaks during the prime.No disconnection or separation was noted at the leak location.All connections were confirmed to be secure prior to treatment initiation.There were no alarms from the machine.The majority of the patient's blood was able to be returned.The patient's estimated blood loss (ebl) due to the leak was 10 ml.The patient did not experience any adverse effects or require medical intervention due to the reported event.The patient was able to complete their treatment after being re-setup with new supplies on a different machine.Following the event, a machine evaluation was performed by a fresenius field service technician (fst) to verify the machine was functioning correctly.A report submitted by the fst confirmed the machine was functioning as expected without problems.Upon follow-up with the user facility, it was confirmed that the bloodline was returned for physical 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: d9, h3.Plant investigation: the complaint sample was returned to the manufacturer for physical evaluation.As the returned sample was being disinfected and prepared for analysis, a leak was found in the venous line at the connection of the venous chamber to the main line.During visual inspection of the assembly (of the main line to the bottom of the venous chamber), a gap was found between the outer wall of the tubing and the inner wall of the drip chamber port.However, during inspection of the bond under a microscope, it was confirmed that the bond had solvent.Although the leak was confirmed, the cause was not due to a lack of solvent.No other problems were found during the visual inspection.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.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.The investigation into the complaint was able to confirm the reported event.
Event or Problem Description
A user facility charge nurse (cn) reported that a 5008x bloodline leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak occurred mid-treatment and was reported to be coming from the connection between the venous chamber and the line that returns to the patient.There were no other known issues leading up to the event, and there were no leaks during the prime.No disconnection or separation was noted at the leak location.All connections were confirmed to be secure prior to treatment initiation.There were no alarms from the machine.The majority of the patient's blood was able to be returned.The patient's estimated blood loss (ebl) due to the leak was 10 ml.The patient did not experience any adverse effects or require medical intervention due to the reported event.The patient was able to complete their treatment after being re-setup with new supplies on a different machine.Following the event, a machine evaluation was performed by a fresenius field service technician (fst) to verify the machine was functioning correctly.A report submitted by the fst confirmed the machine was functioning as expected without problems.Upon follow-up with the user facility, it was confirmed that the bloodline was returned for physical 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: 21494429
• Report Number: 0008030665-2025-00486
• Device Sequence Number: 18246111
• 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): 04/17/2025

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: 03-5100-7
• Device Lot Number: 24LR01214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 5008X MACHINE; 5008X MACHINE; FX CORAL 80 DIALYZER; FX CORAL 80 DIALYZER
• Patient Sex: Female
• Patient Weight: 66 KG