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

Catalog Number	21-0270-25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.Investigation summary: the affected device was returned for evaluation.Visual inspection performed.Ac adapter received in new and unused condition with no damage to the power block or the cord.Functional testing performed.Customer's problem was confirmed.Connected the ac adapter to the solis pump with no indication of power event when the power block is rotated/twisted in the outlet.After swapping the duck head adapter known good test duck head adapter, the ac adapter powered and charged the solis pump properly.The root cause was that the duck head adapter was not making electrical connection with the duck head bill plugs.This is a known duck bill plug connection issue.No repairs will be performed.Item is a pfg and will be scrapped.The service history review was not applicable as the item is a supplied item.
Event or Problem Description
It was reported that the affected ac adaptor did not charge with the cadd solis pump.The ac adaptor was broken.The operator of the device was a health professional.Event occurred at the hospital.There was no patient involvement, and no harm/adverse event reported.

• Brand Name: CADD SOLIS AC ADAPTER
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20538628
• Report Number: 3012307300-2024-12109
• Device Sequence Number: 6772751
• Product Code: FRN
• UDI-Device Identifier: 15019517126884
• UDI-Public: (01)15019517126884
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: Health Professional
• Device Catalogue Number: 21-0270-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CADD-SOLIS, PUMP V4.2.1, ENG
• Patient Sex: Unknown