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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE

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ST PAUL MEDFUSION; SYRINGE Back to Search Results
Model Number 4000
Device Problem Device Alarm System (1012)
Patient Problem Endocarditis (1834)
Event Type  malfunction  
Manufacturer Narrative
Investigation completed on a smiths medical syringe infusion pumps|medfusion 4000 pumps complaint of back up alarm was not confirmed during testing, however it was revealed in the event log.The cause was unkown as the blue tokin super cap present on the main pc board.Action was taken as preventative goal and main pc board was replaced.Device was in over all good condition.Device passed all functional testing.
 
Event Description
Information received a smiths medical syringe infusion pumps|medfusion 4000 pumps malfunctioned as displayed back up audible alarm.No patient adverse events reported.
 
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Brand Name
MEDFUSION
Type of Device
SYRINGE
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
travis
minneapolis, MN 55442
MDR Report Key11828622
MDR Text Key250799561
Report Number3012307300-2021-04369
Device Sequence Number1
Product Code MRZ
UDI-Device Identifier15019517069624
UDI-Public15019517069624
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number4000
Device Catalogue Number4000-0106-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/14/2021
Initial Date FDA Received05/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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