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

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.

• Brand Name: CADD
• Type of Device: PUMP, 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 Key: 11683638
• MDR Text Key: 245963867
• Report Number: 3012307300-2021-03246
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517096378
• UDI-Public: 15019517096378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• 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 Number: 2120
• Device Catalogue Number: 21-2120-0103-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 100