MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBESET,MICROVOL,LOW PRIME,STE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number H938331

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 05/03/2021

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 a repeater pump tube set leaked.It was further reported the tubing had cracked and fluid was leaking from an unspecified location.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from july 10, 2020 - july 15, 2020.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.

• Brand Name: TUBESET,MICROVOL,LOW PRIME,STE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11848323
• MDR Text Key: 251403156
• Report Number: 1416980-2021-03047
• Device Sequence Number: 1
• Product Code: NEP
• 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: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938331
• Device Lot Number: 60248192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1