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

Model Number	2160
Medical Device Problem Codes	Failure to Charge (1085); Pumping Stopped (1503)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received that a smiths medical cadd solis battery pack may have caused the pump to alarm low battery even though it was plugged.The reporter also stated that the battery would not charge up.There were no clinical consequence due to the reported event.

• Brand Name: CADD ACCESSORIES
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10279534
• Report Number: 3012307300-2020-07347
• Device Sequence Number: 2623953
• Product Code: MEA
• UDI-Device Identifier: 10610586031212
• UDI-Public: 10610586031212
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/15/2020

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: No Information
• Device Model Number: 2160
• Device Catalogue Number: 21-2160-02
• 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: 06/30/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1