MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD®-SOLIS RECHARGABLE BATTERY PACK; ACCESSORIES, PUMP, INFUSION

Catalog Number 21-2160-51

Device Problems Charred (1086); Smoking (1585); Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the devices 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 had smoke emitting from the battery compartment within one minute of starting charging.It was noted that the initial reporter received the pump for repair of a no power and will not switch on fault.The charger that returned with the pump had a loose and frayed cable.The reporter then opted to use a "brand new" charger with the pump.After one minute of charging the main power pack battery that was inside the pump, smoke was observed coming from the area of the battery compartment.On seeing this, the reporter stopped the device from charging and removed the battery pack from the unit.The negative terminal inside the pump and that of the battery appeared to be badly charred.No injury was reported.See mfr: 3012307300-2017-00964 and 3012307300-2017-00965.

• Brand Name: CADD®-SOLIS RECHARGABLE BATTERY PACK
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL OAKDALE; 3350 granada avenue north; suite 100; st. paul MN 55128
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6559785
• MDR Text Key: 74916085
• Report Number: 3012307300-2017-01000
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 21-2160-51
• Device Lot Number: 000024 0714C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• 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
• Treatment: CADD®-SOLIS AMBULATORY INFUSION PUMP; CADD®-SOLIS RECHARGABLE BATTERY PACK