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
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that the dark blue female connector disconnected from the light blue main body of the twist clamp on an extended life pd transfer set.The issue occurred during a routine transfer set change when the nurse was disconnecting the patient from a manual exchange of peritoneal dialysis (pd) therapy.There was no report of patient injury associated with this event, however, the patient received an intra peritoneal prophylactic dose of ceftazidime and cefazolin.No additional information is available.
|
|
Manufacturer Narrative
|
B5: on the same day as the event, the patient received a prophylactic first dose of ceftazidime and cefazolin intra peritoneally.H10: the actual sample was received for evaluation.A visual inspection with the naked eye was performed which revealed a separation between the female connector and main body of the twist clamp.Functional tests were performed which included leak, clear passage and clamp function tests with no issues noted.The reported condition was verified.The cause of the condition was determined to be manufacturing related due to an inadequate solvent bond between the female connector, insert chip, and main body of the twist clamp.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|