BAXTER HEALTHCARE CORPORATION EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP; SET, I.V. FLUID TRANSFER
|
Back to Search Results |
|
Catalog Number H938740 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that an unspecified quantity of exactamix 2000 ml eva tpn bags were damaged.The damaged bags were further described as, ¿the bags splitting at the seam just below the hole at the top of the bag where it hangs on an iv pole¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
D4: expiration date: remove 08/31/2026 as previously reported and replace with ni.H4: device manufacture date: remove 11/14/2023 as previously reported.H4: the lot was manufactured september 18, 2023 - september 19, 2023.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
|
|
|