|
Catalog Number 21-7047-24 |
Device Problems
Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
|
Patient Problems
Irritation (1941); No Code Available (3191)
|
Event Date 05/17/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant product(s): the model number of the pump is 6500.Patient code - it was reported that a "serious injury" occurred, however no other details regarding the injury were provided.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
|
|
Event Description
|
It was reported that a chemotherapy leak occurred during use of a cadd administration set.The patient was in the clinic for chemotherapy, and the patient noticed the needle used for infusion was dislodged.The patient returned to the clinic the following day and the port was re-accessed and infusion re-started.The patient experienced a small amount of irritation on their site.Information provided states an event report type of "serious injury", and an event outcome of "required intervention", however details on the injury and intervention were not provided.Additional information regarding the event has been requested, but not yet received.
|
|
Search Alerts/Recalls
|
|
|