CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
|
Back to Search Results |
|
Catalog Number 190713 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Cardiac Arrest (1762)
|
Event Date 06/26/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Clinical review; a temporal relationship exists between hd therapy utilizing the 2008t machine, and the serious adverse event of cardiac arrest.The bmt reported the 2008t machine passed all functional compliance testing following the code and was returned to service.Additionally, the bmt stated there was no allegation against the 2008t machine, and advised the machine was sequestered per the outpatient dialysis clinic¿s procedure following a code.Therefore, based on the totality of the information available, the 2008t machine can be disassociated from the event as there is no allegation or objective evidence indicating a product deficiency or malfunction was associated with the event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
|
|
Event Description
|
It was reported that a patient on hemodialysis (hd) for renal replacement therapy (rrt) coded during hd therapy.Follow-up with the user facility¿s biomedical technician (bmt) confirmed the event(s) occurrence, and the sequestering of the machine following the cardiac arrest.The bmt reported the 2008t hemodialysis machine was inspected (specifics not provided) and cultures were obtained (specifics and results not provided).Reportedly, the 2008t machine passed all functional compliance testing and was returned to service.The bmt confirmed there was no allegation against the 2008t machine, and advised the machine was sequestered per the outpatient dialysis clinic¿s procedure following a code.Additional information regarding the patient and event has been requested; however to date has not been provided.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|