MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 5008X HDF HEMODIALYSIS BLOOD TUBING SET; 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	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility's clinical manager (cm) reported that a fresenius bloodline experienced air in the line during a patient's hemodialysis (hd) treatment resulting in blood loss.Two hours after the initiation of the patient¿s hd treatment, a fresenius 5008x machine alarmed for air in lines and the clinician began the air removal procedure.The lines were placed into circulation, a saline bag was connected, and a syringe was connected to the venous chamber.When the clinician initiated the removal of air via the syringe more air began appearing throughout the lines with no obvious source.The patient¿s blood was not rinsed back following the incident.The patient¿s estimated blood loss (ebl) is 250ml.There was no patient injury or medical intervention required as a result of this event.A fresenius dialyzer was also in use.There was no damage noticed on either the bloodline or the dialyzer.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
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 bloodline experienced air in the line during a patient's hemodialysis (hd) treatment resulting in blood loss.Two hours after the initiation of the patient¿s hd treatment, a fresenius 5008x machine alarmed for air in lines and the clinician began the air removal procedure.The lines were placed into circulation, a saline bag was connected, and a syringe was connected to the venous chamber.When the clinician initiated the removal of air via the syringe more air began appearing throughout the lines with no obvious source.The patient¿s blood was not rinsed back following the incident.The patient¿s estimated blood loss (ebl) is 250ml.There was no patient injury or medical intervention required as a result of this event.A fresenius dialyzer was also in use.There was no damage noticed on either the bloodline or the dialyzer.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: d1, d2a, d2b, d4, g3.
Additional Manufacturer Narrative
Additional information: d, h3.Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During disinfection, no leaks in the venous line nor the arterial line were observed.During the visual inspection no issues or damage was identified.A test underwater was performed up to 15psi and no leaks were detected.The product 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.
Event or Problem Description
A user facility's clinical manager (cm) reported that a fresenius bloodline experienced air in the line during a patient's hemodialysis (hd) treatment resulting in blood loss.Two hours after the initiation of the patient¿s hd treatment, a fresenius 5008x machine alarmed for air in lines and the clinician began the air removal procedure.The lines were placed into circulation, a saline bag was connected, and a syringe was connected to the venous chamber.When the clinician initiated the removal of air via the syringe more air began appearing throughout the lines with no obvious source.The patient¿s blood was not rinsed back following the incident.The patient¿s estimated blood loss (ebl) is 250ml.There was no patient injury or medical intervention required as a result of this event.A fresenius dialyzer was also in use.There was no damage noticed on either the bloodline or the dialyzer.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: h6 "type of investigation" codes additional information: plant investigation plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During disinfection, no leaks in the venous line nor the arterial line were observed.During the visual inspection no issues or damage was identified.A test underwater was performed up to 15psi and no leaks were detected.The product was in the expected condition.A manufacturing review was performed on the products shipped to the customer for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius 5008x bloodlines shipped to this account within the selected time frame.No information was found indicating that the affected product was delivered to the customer.Additionally, the last delivery lot was reviewed, however, no information was found indicating that the affected product was delivered to the customer.As no information was found in the sap system, a device history review (dhr) review could not be completed.Upon completion of the evaluation, the reported event was not confirmed.
Event or Problem Description
A user facility's clinical manager (cm) reported that a fresenius bloodline experienced air in the line during a patient's hemodialysis (hd) treatment resulting in blood loss.Two hours after the initiation of the patient¿s hd treatment, a fresenius 5008x machine alarmed for air in lines and the clinician began the air removal procedure.The lines were placed into circulation, a saline bag was connected, and a syringe was connected to the venous chamber.When the clinician initiated the removal of air via the syringe more air began appearing throughout the lines with no obvious source.The patient¿s blood was not rinsed back following the incident.The patient¿s estimated blood loss (ebl) is 250ml.There was no patient injury or medical intervention required as a result of this event.A fresenius dialyzer was also in use.There was no damage noticed on either the bloodline or the dialyzer.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.

• Brand Name: 5008X HDF HEMODIALYSIS BLOOD TUBING SET
• 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: 21719560
• Report Number: 0008030665-2025-00725
• Device Sequence Number: 15811868
• 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,Followup
• Report Date (Section B): 06/17/2025

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 Catalogue Number: 03-5100-7
• Device Lot Number: UNKNOWN
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 05/26/2025; 06/17/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/02/2025; 06/02/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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 DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 21 KG