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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number ASKU
Device Problems Clamp (757); Difficult to Open or Close (2921)
Patient Problem No Patient Involvement (2645)
Event Date 08/24/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was manufactured at one of the following manufacturing locations: availmed (b)(6). Or baxter healthcare: (b)(6). The device was not returned and the lot number is unknown, therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that an unspecified quantity of "clear clamps" used on ¿exactamix bags¿ were difficult to close (the quantity was reported as all clear clamps received by customer). This issue was identified during setup in the and preparation in the pharmacy prior to patient use. There was no patient involvement. No additional information is available.

 
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Brand NameNI
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
see h10
see h10
see h10
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10550269
MDR Text Key207432000
Report Number1416980-2020-05759
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 09/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberASKU
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Is this a Reprocessed and Reused Single-Use Device? No

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