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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MS3 PUMP; PUMP, INFUSION

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SMITHS MEDICAL ASD, INC. CADD MS3 PUMP; PUMP, INFUSION Back to Search Results
Model Number 7400
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Toxicity (2333)
Event Date 12/03/2019
Event Type  Injury  
Event Description
Spontaneous call from pt's mother who stated pt was admitted to the hosp on (b)(6) 2019 in icu with severe flushing and limited mobility upon standing up; could not clearly explain the symptoms but almost sounded like drug toxicity.Md determined that the pumps malfunctioned and infused drug at faster rate per calculations done in the hosp.Asked mom to confirm serial numbers.Did the reported product fault occur while in use with a pt? yes.Did the product issue cause or contribute to pt or clinical injury? yes.If yes, was any medical intervention provided? see event.Is the actual device available for investigation? yes.Did the pt have a backup device they were able to switch to? unk.What is the outcome of the event? ongoing? yes.Did we replace the device? yes.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
CADD MS3 PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key9445192
MDR Text Key170434258
Report NumberMW5091549
Device Sequence Number1
Product Code FRN
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 12/05/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/04/2020
Device Model Number7400
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/09/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age14 YR
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