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

Catalog Number	H93863
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional Manufacturer Narrative
The lot was manufactured from november 28, 2018 - november 29, 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.
Additional Manufacturer Narrative
B5: upon clarification from the customer, there were two (2) affected trifurcated fluid transfer tube sets that leaked; initially reported as "at least one (1)".H10: both devices were received for evaluation.Visual inspection was performed on both samples which observed leakage and tear in the section of the tubing that wraps around the rotor.The reported condition was verified for both devices.The cause of the condition could not be determined; however, the probable cause is likely due to shipping and/or handling damage.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TUBE SET, STD VOL, TRIFURC, ST
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10125147
• Report Number: 1416980-2020-03173
• Device Sequence Number: 14069638
• Product Code: FPA
• UDI-Device Identifier: 00085412476698
• UDI-Public: (01)00085412476698
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2020

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: H93863
• Device Lot Number: 60161087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 07/14/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/10/2020; 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1