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	Death (1802)
Date of Event	11/19/2020
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 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 2008t machine passed functional testing during the on-site evaluation.The fst did not identify any issues with the machine that could have caused or contributed to the reported event.The machine was determined to be operating within specification and an associated cause could not be determined.Clinical investigation: a temporal relationship does not exist between hd therapy utilizing the 2008t hd machine and the patient¿s death as it was reported the patient expired two hours after disconnection from the machine.The etiology and timeline of the event(s) remains unknown; therefore, causality cannot be established.Presently there is no objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction caused or contributed to the patient¿s expiration.Given the absence of a discharge summary, primary/secondary cause of death, esrd death notification, death certificate and no autopsy report.The 2008t hemodialysis system cannot be excluded from having a possible causal or contributory role in the patient¿s expiration, as there is insufficient evidence to conclude the root cause of the event(s).However, it is well-known the esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.
Event or Problem Description
A hospital biomedical technician requested onsite service from a fresenius field service technician (fst) to evaluate a 2008t hemodialysis (hd) machine.It was reported that a patient expired approximately two hours after an hd treatment was provided on the system.There was no specific allegation this event was related to any deficiency or malfunction of fresenius device(s) or product(s) in the initial reporting.Subsequent attempts to obtain additional information (e.G.Demographics, medical history, end-stage renal disease (esrd) death notification, discharge summary, autopsy report and/or death certificate) have thus far proven unsuccessful.The hospital provided 2008t hd machine was inspected by an fst and it was verified the machine was operating properly.

• 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: 10983408
• Report Number: 2937457-2020-02220
• Device Sequence Number: 13628826
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/20/2020
• Initial Report FDA Received Date: 12/10/2020
• 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; Hospitalization