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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, TRIFURC, ST SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number H93863
Device Problems Fluid 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 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.
 
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Brand NameTUBE SET, STD VOL, TRIFURC, ST
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
AVAILMED
c. industrial lt. 001 mz. 105
no 20905 int a, col cd ind.
tijuana, baja california 22444
MX 22444
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10125147
MDR Text Key194201345
Report Number1416980-2020-03173
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue NumberH93863
Device Lot Number60161087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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