Model Number 393-800 |
Device Problems
Computer Software Problem (1112); Application Program Freezes, Becomes Nonfunctional (4031)
|
Patient Problems
Death (1802); No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/30/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
As part of radiometer medical investigation a statement has been requested from the physician of the hospital.
|
|
Event Description
|
According to the complaint, a user has reported that the abl800 flex had a downtime.After several attempts by the operator to perform blood samples, they decided to restart the analyzer.After completion of restart, the problem was solved and the operator again was able to activate the start of blood sample measuring via pressing the start button as usual.The above mentioned blood sample was taken from a reanimated (resuscitated) patient.The patient unfortunately passed away during analyzer downtime.The head of the laboratory has stated that the downtime was not likely to be held responsible for the death of the patient.
|
|
Manufacturer Narrative
|
From the root cause investigation, it was found that it was a software error.The customer has been informed to make a workaround if needed by: 1.Logoff the current operator.2.Open and close the inlet.When logging on again, the start button should be responsive again when starting a measurement.
|
|
Manufacturer Narrative
|
It was verified by the responsible assistant medical doctor that no causality could be connected between the software problem on the abl800 flex analyzer and the death of the patient.Accordingly, based on the above mentioned details, the following has been changed: b1 (changed), b2 (eliminated), h6 (changed).
|
|
Search Alerts/Recalls
|