Catalog Number 955052 |
Device Problem
No Flow (2991)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/24/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that the prismaflex machine failed during continuous veno-venous hemodiafiltration (cvvhdf) treatment.The calcium syringe worked well during many calcium refills, but then no longer moved.The machine did not show any error messages until the user pushed the syringe change button.The patient had reportedly received less calcium replacement than intended and an unknown amount of calcium was administered.Treatment was terminated without returning the extracorporeal blood to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
The device was not received for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.A device history review revealed no issues that could have caused or contributed to the reported issue.The event history log review analysis showed that no calcium was delivered from the change syringe procedure until the treatment was stopped.A condition where the calcium syringe pump became inactive unexpectedly has been verified.The cause of the event was not determined.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|