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

Catalog Number H93811

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a sterile repeater pump tube set popped off while the pump was pumping which resulted in a leak.This was identified during use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3, h4 and h6.H4: lot manufactured between august 11, 2020 to august 12, 2020.H10: the device was received for evaluation.Unaided eye visual inspection was done, which observed the tube set tubing with a detached spike found loose in a zip lock bag.The reported condition was verified.  by the nature of the sample, no additional tests were performed. the cause of the condition could not be determined.However, the likely cause was, due to inadequate or lack of adhesive being applied, during the manufacturing process.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: 11151739
• MDR Text Key: 228640316
• Report Number: 1416980-2020-08445
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: H93811
• Device Lot Number: 60252529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1