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	01/08/2025
Type of Reportable Event	Malfunction
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 user facility charge nurse reported that a 5008x bloodline blood leak occurred approximately twenty-five minutes after the start of a patient¿s hemodialysis (hd) treatment.The blood leak originated from the connection at the bottom of the venous chamber.It was reported that the machine, a 5008x hd machine, triggered a blood leak sensor alarm.There were no issues during prime, and there were no other known issues leading up to the leak.Additional details were provided upon follow-up with the nurse.The nurse confirmed blood was seen leaking from the connection at the bottom of the venous chamber.Additionally, they reported that physical damage was visible at the connection.The patient's estimated blood loss (ebl) due to the event was 320 ml.This estimate includes blood that leaked as well as what remained in the lines and could not be returned.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 a shortened treatment after restarting on the same machine.A sample was reportedly returned for manufacturer evaluation.
Event or Problem Description
A user facility charge nurse reported that a 5008x bloodline blood leak occurred approximately twenty-five minutes after the start of a patient¿s hemodialysis (hd) treatment.The blood leak originated from the connection at the bottom of the venous chamber.It was reported that the machine, a 5008x hd machine, triggered a blood leak sensor alarm.There were no issues during prime, and there were no other known issues leading up to the leak.Additional details were provided upon follow-up with the nurse.The nurse confirmed blood was seen leaking from the connection at the bottom of the venous chamber.Additionally, they reported that physical damage was visible at the connection.The patient's estimated blood loss (ebl) due to the event was 320 ml.This estimate includes blood that leaked as well as what remained in the lines and could not be returned.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 a shortened treatment after restarting on the same machine.A sample was reportedly returned for manufacturer evaluation.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.
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 on the connection of the venous chamber to the main line.During visual inspection of the connection (from 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.So 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 reported that a 5008x bloodline blood leak occurred approximately twenty-five minutes after the start of a patient¿s hemodialysis (hd) treatment.The blood leak originated from the connection at the bottom of the venous chamber.It was reported that the machine, a 5008x hd machine, triggered a blood leak sensor alarm.There were no issues during prime, and there were no other known issues leading up to the leak.Additional details were provided upon follow-up with the nurse.The nurse confirmed blood was seen leaking from the connection at the bottom of the venous chamber.Additionally, they reported that physical damage was visible at the connection.The patient's estimated blood loss (ebl) due to the event was 320 ml.This estimate includes blood that leaked as well as what remained in the lines and could not be returned.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 a shortened treatment after restarting on the same machine.A sample was reportedly returned for manufacturer evaluation.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.

• 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: 21169800
• Report Number: 0008030665-2025-00124
• Device Sequence Number: 9356656
• 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,Followup
• Report Date (Section B): 03/15/2025

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: 01/08/2025
• Supplement Date Received by Manufacturer: 01/09/2025; 03/04/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 01/20/2025; 03/15/2025
• 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: FRESENIUS 5008X MACHINE; FRESENIUS 5008X MACHINE; FRESENIUS 5008X MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 66 KG