Model Number 8120 |
Device Problems
Break (1069); Contamination (1120); Crack (1135); Inaccurate Delivery (2339); Device Markings/Labelling Problem (2911)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 12/01/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the pca pump module allegedly did not lock out when the maximum dose of 36mg was delivered and exceeded to 40mg at the end.There was patient involvement but unknown impact.Although requested, additional information was not provided.
|
|
Manufacturer Narrative
|
Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.
|
|
Manufacturer Narrative
|
A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.
|
|
Event Description
|
It was reported that the pca pump module allegedly did not lock out when the maximum dose of 36mg was delivered and exceeded to 40mg at the end.There was patient involvement but unknown impact.Although requested, additional information was not provided.
|
|
Search Alerts/Recalls
|