BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
|
Back to Search Results |
|
Catalog Number H93811 |
Device Problem
Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).The devices were manufactured at one of the following manufacturing locations: (b)(4) or baxter healthcare - (b)(4) united states.The devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that the silicone tubing of an unspecified number of sterile repeater pump tube sets had cracks.This issue was identified during use in a lab.It was further reported that twelve (12) gallons of water were pumped per day using the sets.The sets were in use one (1) to three (3) days before the cracked were noted.There was no patient involvement.No additional information is available.
|
|
Search Alerts/Recalls
|
|
|