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

Catalog Number	191124
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/30/2024
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's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) displayed a ¿remove usb device 2¿ message during a patient's hd treatment.Upon follow up, the bmt said that inserting a usb in the usb port resolved the issue, but he was not satisfied with that solution.A fresenius field service technician (fst) was called onsite and replaced the user interface (ui)/ mics board and the usb adaptor cable.Machine functional tests were completed and passed onsite after repair.The patient¿s blood was not returned following this incident.Follow up with the clinic manager revealed that the issue occurred 48 minutes into treatment.The patient¿s estimated blood loss (ebl) was approximately 150ml.There was no patient injury or medical intervention required as a result of this event.Fresenius bloodlines were also in use.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: the product was not returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue the fst replaced the user interface (ui)/ mics board and the usb adaptor cable.Machine functional tests were completed and passed onsite after repair.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 reported problem was able to confirm the reported failure mode.
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) displayed a ¿remove usb device 2¿ message during a patient's hd treatment.Upon follow up, the bmt said that inserting a usb in the usb port resolved the issue, but he was not satisfied with that solution.A fresenius field service technician (fst) was called onsite and replaced the user interface (ui)/ mics board and the usb adaptor cable.Machine functional tests were completed and passed onsite after repair.The patient¿s blood was not returned following this incident.Follow up with the clinic manager revealed that the issue occurred 48 minutes into treatment.The patient¿s estimated blood loss (ebl) was approximately 150ml.There was no patient injury or medical intervention required as a result of this event.Fresenius bloodlines were also in use.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device is not available to be returned to the manufacturer for evaluation.

• Brand Name: 2008T HD SYS. CDX 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: 20493508
• Report Number: 0008030665-2024-00924
• Device Sequence Number: 4174903
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: BN
• 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
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 191124
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 144 KG