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

Model Number	21-2160-51
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical battery pack was implicated in a pump alarming and powering down for no reason.The pumps are being used for a pediatric clinical trial.There were no adverse events reported.

• Brand Name: CADD
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10740102
• Report Number: 3012307300-2020-10648
• Device Sequence Number: 3510108
• Product Code: MEA
• UDI-Device Identifier: 10610586031212
• UDI-Public: 10610586031212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 21-2160-51
• 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: 09/29/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1