As reported, during use in patient in a life-threatening emergency, this disposable pressure transducer (dpt) (medwatch # 45420) unscrewed when connected to the arterial access.It was necessary to redo the entire assembly of the pressure line by manually continuing the purge on the arterial line in order to prevent it from clogging.To solve the issue, a new device was opened (medwatch # 45423), however, it presented the same issue as two of the screw threads were insufficiently screwed.All screw threads were checked before new connection.Patient demographics asked.There was no allegation of patient injury.The devices were not available for evaluation.
|
The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.No root cause could be identified since no product sample nor objective evidence was provided for investigation.In addition, reviews of the device history record revealed no indication that a manufacturing non-conformance contributed to the reported complaint.Current risk mitigation(s) include visual inspection by manufacturing personnel, sampling leak test and sampling flow test.
|