BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
|
Back to Search Results |
|
Catalog Number 5C4482 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
Peritonitis (2252)
|
Event Type
Injury
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a peritoneal dialysis (pd) patient experienced a separation of the transfer set which resulted in peritonitis.The separation was further described as ¿separated at the light blue and dark blue portion after therapy¿ when trying to disconnect the patient.It was reported that when therapy was completed, the caregiver used pliers to disconnect the patient from the patient line ¿due to the transfer set issue¿.The patient went to the emergency room and was diagnosed with peritonitis.The patient was hospitalized for the peritonitis event.On an unknown date, the patient was given unspecified antibiotics for treatment of the peritonitis.It was not reported if pd therapy was ongoing.At the time of this report, the patient outcome was not reported.It was not reported if the patient was retrained on the proper aseptic technique.No additional information is available.
|
|
Manufacturer Narrative
|
Additional information: h6 and h10.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|