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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 NameCADD
Type of DevicePUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11683638
MDR Text Key245963867
Report Number3012307300-2021-03246
Device Sequence Number1
Product Code FRN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 04/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2021
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/26/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/18/2021 Patient Sequence Number: 1
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