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

Model Number	0270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection and functional testing, and the customer problem was not duplicated.The alternating current (ac) power adapter was received in new and good condition, and there was no damage to the power cord or the power block apart from some dents and scratches.The attached european type of plug duck head adapter showed no indication of physical damage or overheating/burn.The manufacturer representative plugged the ac power adapter into an outlet to charge a known good infusion pump.The manufacturer representative touched the lemo connector end and the length of the cord for any active point then twisted/rotated the power block in the outlet.The ac power adapter was found to have no active part exposed.There was no electric shock or discharge when the power cord was plugged-in the power outlet and connected to the pump.Manually touching the length of the cord to the end power plug lemo connector caused no electrical shock or discharges.There was no alteration in the integrity of the cord insulation and the locking mechanism at the duck head adapter connection to the duck head plugs of the power block was operating and latching correctly into place.The manufacturer representative evaluation found no issue with the ac power adapter that would result in electrical shock when connected safely into a power outlet.The manufacturer representative could not duplicate the customer reported issue.
Event or Problem Description
It was reported that a nurse received an electric shock when they went to plug an alternating current (ac) adapter into the socket for charging an infusion pump.Their finger got black, and the skin on their arm was red.It was reported that the facility subsequently checked the socket and nothing is wrong.Additionally, there was no visible damage to the ac adapter.

• Brand Name: AC ADAPTER CADD SOLIS
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21767794
• Report Number: 3012307300-2025-03748
• Device Sequence Number: 15622157
• Product Code: FRN
• UDI-Device Identifier: 15019517126884
• UDI-Public: (01)15019517126884(17)310509(10)2107
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0270
• Device Catalogue Number: 21-0270-25
• Device Lot Number: 2107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female