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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAO PAULO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - SAO PAULO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number AZC9611
Device Problems Fluid Leak (1250); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2018
Event Type  malfunction  
Manufacturer Narrative
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 a solution set was damaged. The reporter stated that after six hours of patient infusion, the nurse noticed that the set was ¿fractured. ¿ this led to a leak of about 50ml of noradrenaline. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameSOLUTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - SAO PAULO
sao paulo
Manufacturer (Section G)
BAXTER HEALTHCARE - SAO PAULO
av. alfredo egidio de souza
aranha, 100, bloco c
sao paulo 47261 70
BR 4726170
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7818757
MDR Text Key118333775
Report Number1416980-2018-05417
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAZC9611
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 Received08/02/2018
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

Patient Treatment Data
Date Received: 08/27/2018 Patient Sequence Number: 1
Treatment
NORADRENALINE
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