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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND IVT DISPOSABLE SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE - CLEVELAND IVT DISPOSABLE SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number 2B8071
Device Problem No Flow (2991)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Event Description

It was reported that there was restricted flow in an ivt disposable. The nurse was able to dispense some solution into the vial, but unable to withdraw about half of the solution back into the bag. There was no patient involvement. No additional information is available.

 
Manufacturer Narrative

(b)(4). Should additional relevant information become available, a supplemental report will be submitted.

 
Manufacturer Narrative

(b)(4). Additional information: the device lot was manufactured between the dates 3/13/15 and 3/17/15. 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 returned; therefore, an evaluation could not be conducted. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand NameIVT DISPOSABLE
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE - CLEVELAND
911 highway 61 north po box 1
cleveland MS 38732
Manufacturer (Section G)
BAXTER HEALTHCARE - CLEVELAND
911 highway 61 north po box 1
cleveland MS 38732
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key4878727
MDR Text Key6064508
Report Number1416980-2015-27171
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/18/2020
Device Catalogue Number2B8071
Device LOT NumberGR15B18043
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/21/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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