MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	191126
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility biomedical technician (bmt) reported the deaeration motor seized and burned up (melting damage) during dialysis treatment mode.There were no adverse reactions with the patient and the patient completed treatment on another device.No blood loss was reported.The bmt stated the deaeration motor had been running for about 24,000 machine hours.The resulting machine symptoms were a low flow error and a bibag: pressure too low alarm.The motor was replaced and the machine was running with no further issues.Upon follow-up, the bmt stated the deaeration motor was replaced to resolve the reported issue.The machine is back in service.It is confirmed there was patient involvement with this issue and the patient was switched onto another machine to complete treatment and there was no harm or adverse event reported.The bmt stated a burning smell was noted and there were no signs of any smoke, sparks, or flames, and no other components were noted to have been burnt or charred.The bmt stated no other components were observed to be damaged.It was confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt stated the machine had no previous history of failing the electrical leakage test.The damaged deaeration motor was discarded and was no longer available to be returned for evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.
Event or Problem Description
A user facility biomedical technician (bmt) reported the deaeration motor seized and burned up (melting damage) during dialysis treatment mode.There were no adverse reactions with the patient and the patient completed treatment on another device.No blood loss was reported.The bmt stated the deaeration motor had been running for about 24,000 machine hours.The resulting machine symptoms were a low flow error and a bibag: pressure too low alarm.The motor was replaced and the machine was running with no further issues.Upon follow-up, the bmt stated the deaeration motor was replaced to resolve the reported issue.The machine is back in service.It is confirmed there was patient involvement with this issue and the patient was switched onto another machine to complete treatment and there was no harm or adverse event reported.The bmt stated a burning smell was noted and there were no signs of any smoke, sparks, or flames, and no other components were noted to have been burnt or charred.The bmt stated no other components were observed to be damaged.It was confirmed the machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt stated the machine had no previous history of failing the electrical leakage test.The damaged deaeration motor was discarded and was no longer available to be returned for evaluation.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 23898433
• Report Number: 0008030665-2025-03101
• Device Sequence Number: 10388885
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: Other
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Sex: Unknown