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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. CADD; PUMP, INFUSION Back to Search Results
Model Number 2120
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Oversedation (1990)
Event Date 03/12/2021
Event Type  Death  
Event Description
It was reported that a smiths medical cadd pumps was programed per the nurse practitioner's orders for continuous infusion of dilaudid and the settings were verified by 2 nurses.The infusion was started at 1228 and checked at 1330.The iv bag was almost empty and the infusion was stopped.The order was checked and the drug concentration was verified.The nurse determined that the drug concentration was programmed incorrectly in the pump.The primary and secondary nurse assessed the patient and the physician and nurse practitioner were summoned.The patient was pronounced dead at 1545.We conducted some performance testing and determined that the pump was infusing too rapidly.It was infusing at four times the programmed rate.
 
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Brand Name
CADD
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11683638
MDR Text Key245963867
Report Number3012307300-2021-03246
Device Sequence Number1
Product Code FRN
UDI-Device Identifier15019517096378
UDI-Public15019517096378
Combination Product (y/n)N
PMA/PMN Number
K111275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2120
Device Catalogue Number21-2120-0103-51
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/19/2021
Initial Date FDA Received04/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age69 YR
Patient Weight100
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