MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190610
Medical Device Problem Codes	Mechanical Problem (1384); Reflux within Device (1522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
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 biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008k2 hemodialysis (hd) machine displayed a ¿filling program¿ message during recirculation causing the saline bag to fill.There were no audible alarms.The machine does not have an air separator adapter board installed.The ts representative advised the biomed to install an air separator board.Additional information was provided upon follow-up with the biomed.The biomed confirmed the machine was giving a "filling program" message.There were no other alarms or messages.The biomed did not witness it happen, but nurses reported to the biomed that they saw fluid backflowing into the saline bag during recirculation.The saline bag was refilling with dialsyate.The biomed was unsure if the machine had the cbe upgrades completed.They confirmed the machine was passing all pressure and alarm tests.The biomed could not speak to whether or not user error was a factor.It was confirmed that the drain line length and height were both within specification, and there were no quick disconnects used on the drain line.There was no patient involvement associated with the event.The backfill occurred during startup while the machine was being prepped.Upon further inspection of the machine, the biomed discovered a leak coming from the high flow relief valve.The biomed indicated there was a crack on the component.The biomed replaced the valve and this resolved the issue.The damaged valve was discarded.The machine was returned to service with no further issues encountered during recirculation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the saline bag refilling with dialysate cannot be reached without a physical examination of the complaint device.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008k2 hemodialysis (hd) machine displayed a ¿filling program¿ message during recirculation causing the saline bag to fill.There were no audible alarms.The machine does not have an air separator adapter board installed.The ts representative advised the biomed to install an air separator board.Additional information was provided upon follow-up with the biomed.The biomed confirmed the machine was giving a "filling program" message.There were no other alarms or messages.The biomed did not witness it happen, but nurses reported to the biomed that they saw fluid backflowing into the saline bag during recirculation.The saline bag was refilling with dialsyate.The biomed was unsure if the machine had the cbe upgrades completed.They confirmed the machine was passing all pressure and alarm tests.The biomed could not speak to whether or not user error was a factor.It was confirmed that the drain line length and height were both within specification, and there were no quick disconnects used on the drain line.There was no patient involvement associated with the event.The backfill occurred during startup while the machine was being prepped.Upon further inspection of the machine, the biomed discovered a leak coming from the high flow relief valve.The biomed indicated there was a crack on the component.The biomed replaced the valve and this resolved the issue.The damaged valve was discarded.The machine was returned to service with no further issues encountered during recirculation.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 20825231
• Report Number: 0008030665-2024-01163
• Device Sequence Number: 8928847
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K994267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2026

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: 190610
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 03/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2010
• 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
• Patient Sex: Unknown