The event occurred at 3pm and involved a add on kit w/03 ml safeset¿ reservoir and 2" red stripe pt tubing that the customer reported a disconnection distal to the safeset reservoir.The device was in use for 8 hours and no medication was being used with the device.There was patient involvement and a delay in therapy, however, no report of adverse event.This is the third of three events reported.
|
Received one new list# 011-46105-77, add on kit w/03 ml safeset¿ reservoir and 2" red stripe pt tubing.Lot# 4944824, one new list# 011-46105-77, add on kit w/03 ml safeset¿ reservoir and 2" red stripe pt tubing.Lot# 4916116, one empty pouch with list# 011-46105-77, add on kit w/03 ml safeset¿ reservoir and 2" red stripe pt tubing.Lot# 3817662.The reported complaint of product disconnection was not confirmed on the returned sets.No visual anomalies were observed on the returned new sets.The returned sets were primed and pressure leak tested and no leaks were observed.The products had performed per the specifications.Without the return of the reported sample the complaint could not confirmed.A device history review (dhr) lot# 4944824, 4916116 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
|