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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PUMP CADD LEGACY; PUMP, INFUSION, PCA
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SMITHS MEDICAL ASD, INC. PUMP CADD LEGACY; PUMP, INFUSION, PCA Back to Search Results
Model Number 6400
Device Problem Pumping Problem (3016)
Patient Problem Dizziness (2194)
Event Date 09/25/2020
Event Type  Injury  
Event Description
Via spontaneous call, pt reported pump malfunctioned today.Serial number (b)(4).Pump stared beeping with error message "no disposable, pump won't run." she tried detaching and reattaching cassette and tried turning off and on pump.Nothing worked.She spent 10 mins trying to troubleshoot and then switched to backup pump, which is working fine.She reported an interruption of infusion of 10 mins and she felt dizzy, like she was going to pass out.She is feeling better now that infusion has been restarted.She put on her oxygen and is limiting her physical activity.Advised pt to continue to monitor herself and call the pharmacy if she has any issues.Advised that pharmacy will send replacement pump.No other info or dates are known or were provided.Is the actual device available to be returned for investigation? yes; did we replace device? yes; did the patient have a backup they were able to switch to? yes; if yes, was the patient able to successfully continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved? ongoing? resolved, sending replacement pump.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
PUMP CADD LEGACY
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key10627935
MDR Text Key209989353
Report NumberMW5097049
Device Sequence Number1
Product Code MEA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6400
Device Lot Number
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Age42 YR
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