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	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility¿s clinic manager (cm) reported that 1 hour into a patient's hemodialysis (hd) treatment, a fresenius 5008x bloodline had air in it.The fresenius 5008x hd machine alarmed appropriately with an ¿air in line¿ alarm.A fresenius dialyzer was also in use.The air removal procedure was followed, but air continued to appear.After initiating the air removal procedure, a blood leak was noted to originate from the arterial pressure dome.There were no loose connections, no issues noted during prime and no changes in pressure during treatment.The patient¿s estimated blood loss (ebl) was approximately 260ml.There was no patient serious 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 patient lost thirty minutes of treatment due to the interruption.The complaint device is available to be returned to the manufacturer for evaluation.A photo has been provided.
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, h7, h9 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the disinfection of the complaint product sample no leaks or other problems were observed.The complaint product sample was visually inspected under the microscope.During the inspection, a syringe was used to inject a mixture of blue dye and water into the sample.This revealed a leak at the connection between the pressure dome (pod) and the main line assembled to the borla h valve.A gap was observed between the walls of the dome and the tube, and no dryness channel was found.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 1 hour into a patient's hemodialysis (hd) treatment, a fresenius 5008x bloodline had air in it.The fresenius 5008x hd machine alarmed appropriately with an ¿air in line¿ alarm.A fresenius dialyzer was also in use.The air removal procedure was followed, but air continued to appear.After initiating the air removal procedure, a blood leak was noted to originate from the arterial pressure dome.There were no loose connections, no issues noted during prime and no changes in pressure during treatment.The patient¿s estimated blood loss (ebl) was approximately 260ml.There was no patient serious 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 patient lost thirty minutes of treatment due to the interruption.The complaint device is available to be returned to the manufacturer for evaluation.A photo has been provided.

• 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: 22176245
• Report Number: 0008030665-2025-01305
• Device Sequence Number: 7799097
• 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
• Report Date (Section B): 06/30/2025

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: 05/31/2026
• Device Catalogue Number: 03-5100-7
• Device Lot Number: 25ER01800
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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 HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 72 KG