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	04/28/2025
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¿s clinic manager (cm) reported that a fresenius 5008x bloodline leaked immediately after the initiation of a patient¿s hemodialysis (hd) treatment.The leak originated from a broken connection at the bottom of the venous chamber.The machine, a fresenius 5008x machine, did not alarm, but was not expected to.A fresenius dialyzer was also in use.The patient¿s estimated blood loss (ebl) was approximately 25ml.There was no patient serious injury or medical intervention required as a result of this event.The patient was restarted on a new 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
Additional information: d9, h3, h7, h9.Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.As the complaint product sample was being disinfected and prepared for analysis, it was discovered that the venous chamber was separated from the main line tubing.The complaint product sample was visually inspected and found that the main line tubing has a presence of solvent, however, the tube was not fully assembled to the port venous chamber.As the tube can be observed, all the tube has solvent present, however, only the tip was assembled.After further inspection no other problems were found with the product.A dimensional test was performed and the test results were acceptable.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.Upon completion of the evaluation, the reported event was confirmed.
Event or Problem Description
A user facility's clinic manager (cm) reported that a fresenius 5008x bloodline leaked immediately after the initiation of a patient¿s hemodialysis (hd) treatment.The leak originated from a broken connection at the bottom of the venous chamber.The machine, a fresenius 5008x machine, did not alarm, but was not expected to.A fresenius dialyzer was also in use.The patient¿s estimated blood loss (ebl) was approximately 25 ml.There was no patient serious injury or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Event or Problem Description
A user facility¿s clinic manager (cm) reported that a fresenius 5008x bloodline leaked immediately after the initiation of a patient¿s hemodialysis (hd) treatment.The leak originated from a broken connection at the bottom of the venous chamber.The machine, a fresenius 5008x machine, did not alarm, but was not expected to.A fresenius dialyzer was also in use.The patient¿s estimated blood loss (ebl) was approximately 25ml.There was no patient serious injury or medical intervention required as a result of this event.The patient was restarted on a new 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
Corrected information: a4.

• 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: 21968618
• Report Number: 0008030665-2025-01026
• Device Sequence Number: 8142145
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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: 12/31/2025
• Device Catalogue Number: 03-5100-7
• Device Lot Number: 24SR01010
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 09/08/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/25/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 96827
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG