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

Model Number 21-2111-0200-02

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a cadd®-solis ambulatory infusion pump was setup for a test with a battery and ac adapter to update the software when after a few minutes, the technician observed a smoke and burning smell from the pump.The pump was not in use with a patient.No injury was reported.

Manufacturer Narrative

One pump was returned for evaluation.Visual inspection of the pump battery pack found visible damage and the pump had black charred markings in the battery compartment.Functional testing of the battery found a fault in the rechargeable lithium ion battery back, which caused the battery pack to overheat in the pump and caused damage, smoke, and odor in the housing.The fault was confirmed as it was observed that the led of the battery pack did not illuminate when connected to an ac adapter to charge.Based on the evidence, it was determined that the root cause was attributed to a supplier issue.

• Brand Name: CADD®-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 3350 granada avenue; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6421616
• MDR Text Key: 70522140
• Report Number: 3012307300-2017-00709
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-2111-0200-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2011
• 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