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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL MEDFUSION; PUMP, INFUSION

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ST PAUL MEDFUSION; PUMP, INFUSION Back to Search Results
Model Number 4000
Device Problem No Flow (2991)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional contact: (b)(6).
 
Event Description
Information was received indicating that a smiths medical medfusion pump did not deliver medication.The pump alarmed for completed infusion, but the volume was still in the syringe.There was no reported adverse event.
 
Manufacturer Narrative
Other, other text: b5: updated with additional information.H6: patient code updated reflect code 4582.
 
Event Description
It was further reported that the event occurred on 23 february 2021.The incident involving the product malfunction did not necessitate any medical intervention outside of using an alternative medfusion pump to complete the infusions.The medications that were being infused were not a life-sustaining medications.The incident was described as resolved.The affected pump was not returned to the manufacturer for device evaluation.
 
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Brand Name
MEDFUSION
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11679412
MDR Text Key245829395
Report Number3012307300-2021-03217
Device Sequence Number1
Product Code FRN
UDI-Device Identifier15019517069624
UDI-Public15019517069624
Combination Product (y/n)N
PMA/PMN Number
K111386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/07/2021
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? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/18/2021
Initial Date FDA Received04/16/2021
Supplement Dates Manufacturer Received05/13/2021
Supplement Dates FDA Received06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age3 DA
Patient Weight3
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