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	05/19/2025
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 four minutes after the initiation of the patient¿s hemodialysis (hd) treatment a fresenius 5008x hd machine displayed ¿btm: no lines detected or btm doors open¿ and ¿arterial pressure measurement error¿ alarms.It was noted that there was air throughout the lines both before & after the dialyzer, initiating around the arterial pressure pod.Fresenius 5008x bloodlines and a fresenius dialyzer were in use.They attempted to reinfuse the patient with saline, but there was too much air in the lines.Additionally, it was noted that blood was dripping down from the arterial pressure dome.There were no loose connections.There no issues noted during priming.There were no changes or disruptions in pressure during treatment.There was no visible damage or defect on the bloodline.The patient¿s estimated blood loss (ebl) was approximately 200ml.There was no patient serious injury or medical intervention required as a result of this event.The patient chose to end the treatment twenty minutes early.The complaint devices were reported to be available to be returned to the manufacturer for evaluation, but tracking numbers were not available.Three photos have been provided.A fresenius field service technician (fst) was called onsite to repair the 5008x hd machine and verified that the machine was functioning correctly.Machine functional tests were completed and passed onsite after repair.
Event or Problem Description
A user facility¿s clinic manager (cm) reported that four minutes after the initiation of the patient¿s hemodialysis (hd) treatment a fresenius 5008x hd machine displayed ¿btm: no lines detected or btm doors open¿ and ¿arterial pressure measurement error¿ alarms.It was noted that there was air throughout the lines both before & after the dialyzer, initiating around the arterial pressure pod.Fresenius 5008x bloodlines and a fresenius dialyzer were in use.They attempted to reinfuse the patient with saline, but there was too much air in the lines.Additionally, it was noted that blood was dripping down from the arterial pressure dome.There were no loose connections.There no issues noted during priming.There were no changes or disruptions in pressure during treatment.There was no visible damage or defect on the bloodline.The patient¿s estimated blood loss (ebl) was approximately 200ml.There was no patient serious injury or medical intervention required as a result of this event.The patient chose to end the treatment twenty minutes early.The complaint devices were reported to be available to be returned to the manufacturer for evaluation, but tracking numbers were not available.Three photos have been provided.A fresenius field service technician (fst) was called onsite to repair the 5008x hd machine and verified that the machine was functioning correctly.Machine functional tests were completed and passed onsite after repair.
Additional Manufacturer Narrative
Additional information: h7, h9 correction: plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the disinfection of the complaint product sample a leak on the main line assembled to the arterial pressure dome was found.The complaint product sample was visually inspected and a gap was observed between the walls of the dome and the tube.No dryness channel was found.No other damage was found to the product.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 four minutes after the initiation of the patient¿s hemodialysis (hd) treatment a fresenius 5008x hd machine displayed ¿btm: no lines detected or btm doors open¿ and ¿arterial pressure measurement error¿ alarms.It was noted that there was air throughout the lines both before & after the dialyzer, initiating around the arterial pressure pod.Fresenius 5008x bloodlines and a fresenius dialyzer were in use.They attempted to reinfuse the patient with saline, but there was too much air in the lines.Additionally, it was noted that blood was dripping down from the arterial pressure dome.There were no loose connections.There no issues noted during priming.There were no changes or disruptions in pressure during treatment.There was no visible damage or defect on the bloodline.The patient¿s estimated blood loss (ebl) was approximately 200ml.There was no patient serious injury or medical intervention required as a result of this event.The patient chose to end the treatment twenty minutes early.The complaint devices were reported to be available to be returned to the manufacturer for evaluation, but tracking numbers were not available.Three photos have been provided.A fresenius field service technician (fst) was called onsite to repair the 5008x hd machine and verified that the machine was functioning correctly.Machine functional tests were completed and passed onsite after repair.
Additional Manufacturer Narrative
Additional information: d9, h3 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, a leak was found on the main line assembled to the arterial pressure dome.The complaint product sample was visually inspected and a dryness channel in the connection between the pressure dome and the main line was found.No other damage was found to the product.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.

• 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: 22135579
• Report Number: 0008030665-2025-01255
• Device Sequence Number: 18267727
• 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): 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 06/27/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/25/2025; 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 DIALYZER; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Sex: Female
• Patient Weight: 67 KG