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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VALVE SET, EM2400 SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION VALVE SET, EM2400 SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938724
Device Problems Improper Flow or Infusion (2954); No Flow (2991)
Patient Problem No Patient Involvement (2645)
Event Date 02/28/2020
Event Type  Malfunction  
Manufacturer Narrative

The devices were discarded; 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 three (3) em2400 valve sets had air bubbles which caused occlusions. This was identified during setup/preparation. There was no patient involvement. No additional information is available.

 
Manufacturer Narrative

Additional information was added: the lot was manufactured from february 10, 2018 - february 13, 2018. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The devices were not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand NameVALVE SET, EM2400
Type of DeviceSET, I.V. FLUID TRANSFER
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 Key9872869
MDR Text Key184703613
Report Number1416980-2020-01670
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK002705
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
Report Date 04/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date10/31/2020
Device Catalogue NumberH938724
Device LOT Number60110775
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 Received03/27/2020
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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