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

Catalog Number 21-2140-25

Device Problems Electrical Power Problem (2925); Power Problem (3010); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

One used ac adapter was returned for product inspection.During functional testing, the returned ac adapter was attached to a test pump (not the pump associated with the report, but of the same make/model) and the pump powered up properly without signs of smoke or distress.The ac adapter showed no signs of damage and was found to be functioning properly.It should be noted that the pump associated with the report was not returned with the adapter.No corrective actions are planned at this time as the reported product issue could not be confirmed.

Event Description

User facility reported that the device was in use with infusion pump when the ac adapter began to smoke and smell of smoke.No adverse effects to patients or users reported.

• Brand Name: CADD SOLIS AC ADAPTER
• Type of Device: AC ADAPTER
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5505218
• MDR Text Key: 40526025
• Report Number: 2183502-2016-00545
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2024
• Device Catalogue Number: 21-2140-25
• Device Lot Number: 2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1