MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, TRIFURC, ST; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number H93863

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that at least 1 trifurcated fluid transfer tube set leaked from a tear on the tubing which was threaded around the rotor.It was further reported that the pump was setup up with the port of the tubing connected to a 1l 0.9% normal saline bag and the outlet end of the tubing was setup with an 18 gauge needle.The pump setting was on high 7.This issue was identified during preparation of an empty bag.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufactured from july 11, 2018 - july 12, 2018.The device was received for evaluation.Visual inspection was performed which observed leakage and tear in the section of the tubing that wraps around the rotor.A functional testing was performed which revealed a leak on the affected area.The reported condition was verified.The cause of the condition was not determined.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, TRIFURC, ST
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10125125
• MDR Text Key: 194200490
• Report Number: 1416980-2020-03174
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412476698
• UDI-Public: (01)00085412476698
• Combination Product (y/n): N
• PMA/PMN Number: K062909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: H93863
• Device Lot Number: 60137395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1