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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 Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Investigation completed on a smiths medical syringe infusion pumps|medfusion 4000 pumps motor rate error was not revealed in the event log and during testing the event was not duplicated as multiple occlusion testing was done.The physical condition of the device reveled a top case chipped and front corner chipped.Preventative action was taken to replace the motor assembly as this was five years old.Device then passed all functional testing.
 
Event Description
Information received a smiths medical syringe infusion pumps|medfusion 4000 revealed motor error.No patient adverse events reported.
 
Manufacturer Narrative
Other text: additional information was received by smiths medical on (b)(6) 2021 that the reported problem was found during annual pm testing.
 
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Brand Name
MEDFUSION
Type of Device
SYRINGE
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11404998
MDR Text Key234458847
Report Number3012307300-2021-01690
Device Sequence Number1
Product Code MRZ
UDI-Device Identifier10610586043567
UDI-Public10610586043567
Combination Product (y/n)N
PMA/PMN Number
K111386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/09/2021
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 Number4000-0105-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/03/2021
Initial Date FDA Received03/03/2021
Supplement Dates Manufacturer Received03/12/2021
Supplement Dates FDA Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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