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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD HIGH VOLUME ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD HIGH VOLUME ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7361-24
Device Problems Fluid Leak (1250); Defective Device (2588); Infusion or Flow Problem (2964)
Patient Problems Fever (1858); Chills (2191); Myalgia (2238); Shaking/Tremors (2515); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 04/09/2021
Event Type  Injury  
Event Description
Found liquid (saline hydration infusion) dripping from side of cassette that attaches cadd high volume administration set to my cadd infusion pump. Had been having symptoms of muscle pains, muscle cramping, fevers, chills, and incontrollable shaking while infusing for 2-3 months. After finding the dripping, and documenting with video that it was coming from administration set and not the infusion pump itself my home health company told me to trash the remaining sets i had in possession and sent me a new type of set. Since discontinuing use of same type ( ref (b)(4), lot 4057950) administration sets symptoms have completely resolved and infusions have returned to normal use ( because of symptoms i was not able to do all prescribed infusions). Have video and photos of defect in multiple units. Fda safety report id# (b)(4).
 
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Brand NameCADD HIGH VOLUME ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11900752
MDR Text Key253563212
Report NumberMW5101604
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7361-24
Device Lot Number4057950
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/27/2021 Patient Sequence Number: 1
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