MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	191128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius fst.The fst reported that the machine passed all functional checks.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 fresenius fst was unable to identify any problems with the hemodialysis (hd) machine during testing.The 2008t hd machine performed as designed and no problems were detected.Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, and the serious adverse event of death, as the patient was actively undergoing hd therapy when the events began.The definitive cause of the patients death is unknown; therefore, causality cannot be established.The end-stage renal disease (esrd) population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Based on the totality of the information available, the 2008t hemodialysis system cannot be excluded from having a possible contributory role in the patients death.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred.However, the patient was actively undergoing hd therapy when they expired.Therefore, without a death certificate, esrd death notification, discharge summary and/or autopsy report, this clinical investigation cannot disassociate the device from the serious adverse events.
Event or Problem Description
A hospital biomedical technician requested a hemodialysis (hd) machine evaluation from fresenius technical services following an event where an hd patient expired during hd therapy (exact date unknown) on a fresenius 2008t hd machine.No additional adverse event information was provided during intake.The 2008t hd machine was sequestered following the event(s).A fresenius field service technician (fst) went onsite and performed functional compliance testing/verification on the machine.The 2008t hemodialysis system performed as expected per the manufacturers specifications.Subsequent attempts to obtain additional information (e.G., treatment record, discharge summary, death certificate, patient demographics) have thus far proven unsuccessful.

• Brand Name: 2008T HD SYS. W/O CDX BLUE STAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 12289889
• Report Number: 2937457-2021-01639
• Device Sequence Number: 4664074
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 191128
• Device Catalogue Number: 191128
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death