MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number H93811

Device Problems Device Dislodged or Dislocated (2923); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of three (3) sterile repeater pump tube sets were not working with a baxter pump.The issue was identified during preparation/reconstitution.The pump was used to reconstitute cefazolin 100g smartpaks.It was further reported that "liquid would not come and only air was going in"."the tubing was then changed to see if that was the issue.When the tubing was removed it was very loose around the spinner which is not normal.Continued with the same process for another bag of cefazolin and the same issues occurred.It looked like the pump was struggling to pull the water out of the bulk sterile water bag.The tubing was very loose after removing it the second time." a new tube set from a different lot was used with no further issues.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to b5, d9, h3, h4, h6, h10.B5: during follow up, it was clarified that five (5) units were affected.H4: the lot was manufactured between march 23, 2021 to march 24, 2021.H10: three (3) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed with no issues noted.The reported condition was not verified.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.

• Brand Name: TUBE SET, STD VOL, STER
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12288407
• MDR Text Key: 265408735
• Report Number: 1416980-2021-04836
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412475721
• UDI-Public: (01)00085412475721
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: H93811
• Device Lot Number: 60286192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1