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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION PUMP; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. MEDFUSION PUMP; PUMP, INFUSION Back to Search Results
Model Number 3500
Device Problems Device Alarm System (1012); Electrical /Electronic Property Problem (1198)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical medfusion pump's main board was bad because the errors aren't consistent, sometimes the pump fails and sometimes it doesn't.The pump was charged overnight and still had errors.There was no reported adverse event.
 
Manufacturer Narrative
One medfusion pump was received with the top case cracked by the corners and tubing guides.The event history log was reviewed and there was a supercap post error.The power up process was conducted and a super cap post was found at power up.The black low profile supercap on the main board did not operate as intended.No damage was found on the main board and the cause of the issue was unable to be determined.The main board was replaced to resolve the issue.
 
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Brand Name
MEDFUSION PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key9772568
MDR Text Key181535194
Report Number3012307300-2020-01705
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10610586032318
UDI-Public10610586032318
Combination Product (y/n)N
PMA/PMN Number
K040899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Type of Report Initial,Followup
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3500
Device Catalogue Number3500-500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2020
Date Manufacturer Received03/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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