MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG; HEMODIALYSIS SYSTEM FOR HOME USE

Catalog Number	190904
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/30/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k @home hemodialysis system w/bibag, and the adverse event of death.Based on the information available, the etiology of the patient¿s expiration is unknown; therefore causality cannot be determined.However, it is known that end stage renal disease (esrd) patients receiving renal replacement therapy (rrt) have a significantly higher mortality rating, when compared to the general population.Furthermore, there is no indication and/or documentation the 2008k @home hemodialysis system w/bibag caused or contributed to the adverse event.Additionally, there is no allegation of a malfunction or of the machine failing to perform as expected in relation to this event as evidenced by the completed regional equipment specialist (res) service records.
Event or Problem Description
A user facility reported a patient who expired during their (b)(6) 2018 dialysis treatment while using a fresenius 2008k@home hemodialysis machine.There were no machine alarms reported.Due diligence attempts were exhausted, but no additional information was provided.
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 regional equipment specialist (res).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 complaint incident cannot be reached without a physical examination of the complaint device.
Additional Manufacturer Narrative
Updated plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius regional equipment specialist (res), who determined that the machine passed the ultrafiltration function test and all other functional checks.The res noted that the machine displayed a high flow error once for two seconds, which did not reappear.The customer reportedly would perform a repair on the flow recirculation error at a later date.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.
Additional Manufacturer Narrative
Updated plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius regional equipment specialist (res), who determined that the machine passed the ultrafiltration function test and all other functional checks.The res noted that the machine displayed a high flow error once for two seconds, which did not reappear.The customer reportedly would perform a repair on the flow recirculation error at a later date.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.

• Brand Name: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
• Common Device Name: HEMODIALYSIS SYSTEM FOR HOME USE
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7789626
• Report Number: 2937457-2018-02371
• Device Sequence Number: 19284776
• Product Code: ONW
• UDI-Device Identifier: 00840861100965
• UDI-Public: 00840861100965
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K124035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 190904
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 08/23/2018; 08/01/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 08/28/2018; 08/29/2018; 08/30/2018
• 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