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	05/09/2025
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 clinical manager (cm) reported that a fresenius 5008x bloodline had air in it two and a half hours after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, alarmed appropriately with an air in line alarm.The origin of the leak is unknown.There were no loose connections and there was no damage or defect noted on the bloodline.Additionally, there were no changes or disruptions in pressure during treatment.The clinician initiated the air removal procedure per policy via a 10cc syringe, however more & more air began appearing throughout the lines with no obvious source.There was no indication that the plunger became dislodged.No visible blood was noted on the inside wall of the arterial pressure measurement dome.After performing the air removal procedure per policy 3 times, the air in line alarm continued to appear.At that point, the patient¿s treatment was ended one hour early.Their blood was not returned and the patient¿s estimated blood loss (ebl) was approximately 250ml.There was no patient serious injury or medical intervention required as a result of this event.A fresenius dialyzer was in use.The complaint device was reported to be available to be returned to the manufacturer for evaluation.The tracking number for the sample return kit is not available.The machine serial number was not provided.The machine error log and flight recorder files were not provided.
Event or Problem Description
A user facility's clinical manager (cm) reported that a fresenius 5008x bloodline had air in it two and a half hours after the initiation of the patient's hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, alarmed appropriately with an air in line alarm.The origin of the leak is unknown.There were no loose connections and there was no damage or defect noted on the bloodline.Additionally, there were no changes or disruptions in pressure during treatment.The clinician initiated the air removal procedure per policy via a 10 cc syringe; however, more and more air began appearing throughout the lines with no obvious source.There was no indication that the plunger became dislodged.No visible blood was noted on the inside wall of the arterial pressure measurement dome.After performing the air removal procedure per policy 3 times, the air in line alarm continued to appear.At that point, the patient¿s treatment was ended one hour early.Their blood was not returned and the patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient serious injury or medical intervention required as a result of this event.A fresenius dialyzer was in use.The complaint device was reported to be available to be returned to the manufacturer for evaluation.The tracking number for the sample return kit is not available.The machine serial number was not provided.The machine error log and flight recorder files were not provided.
Additional Manufacturer Narrative
Additional information: d9, h3, h7, h9.Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.As the sample was being disinfected and prepared for analysis, no leak, kink nor any damage was found on the product.The set was in the expected condition.The sample was visually inspected and no leak, kink nor any damage was found on the product.After further inspection no damage was found, the set was in the expected condition.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 not confirmed.

• 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: 22073963
• Report Number: 0008030665-2025-01155
• Device Sequence Number: 9337818
• 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: 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: 05/09/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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 HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 73 KG