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

Model Number	2120
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	03/12/2021
Type of Reportable Event	Death
Event or Problem 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
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11683638
• Report Number: 3012307300-2021-03246
• Device Sequence Number: 12943231
• Product Code: FRN
• UDI-Device Identifier: 15019517096378
• UDI-Public: 15019517096378
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Weight: 100