Model Number CSE-P-125-JA |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/30/2022 |
Event Type
malfunction
|
Event Description
|
On (b)(6) 2022, haemonetics was notified of a "long hour returning message appeared at 3rd cycle returning.At earlier stage detected liquid message appeared at 4th cycle filling" during a procedure in japan, utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.There was no reported impact to patient health.
|
|
Manufacturer Narrative
|
On (b)(6) 2022 the complaint investigation of the returned bowl from the cell saver® elite set - 125ml confirmed a crack in the inner core base.Although there was no injury or harm to the patient, past reporting (1219343-2020-00001-01) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of 1219343-2020-00001-01 indicated the inner core of the bowl malfunctioned via a crack but did not cause or contribute to the reported incident according to the surgeon that performed the surgery.Haemonetics decided to conservatively report inner core cracks that are confirmed by manufacturing due to the event of the past report.
|
|
Search Alerts/Recalls
|