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

Catalog Number 21-2112-0300

Device Problems Melted (1385); Smoking (1585); Sparking (2595); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

Pump was not in use during following described incident.Following use, the ac adaptor was connected to the pump.About 30 minutes after connection, smoke was noticed to be coming from the pump.The ac adaptor was immediately switched off.A small spark was observed coming from the pump.Pump was then stopped and it was then noticed that the side of the pump located around the connection to the ac adaptor had melted.Biomed noted that the mains power cable being used at the time of this event was not standard for the hospital.They were unsure where it had come from.No patient involvement or adverse health outcome as a result of this event.

Manufacturer Narrative

Correction to initial mdr needed.New information available regarding event.Pump and ac adapter was in use on patient during reported event.The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

User facility reported that during use of the pump for infusion of medication, smoke was found coming from side of the pump.Inspection of the device found that the side of the pump around the connection to the ac adaptor had melted.The user facility reported that the pump had been programmed and attached to patient in the operating theatre.The patient was transported to recovery where staff noticed that the ac adapter was not attached, according to standard practice.Therefore, the ac adapter was plugged into the pump.After about 30 minutes, smoke was noticed coming from the pump at which point the ac adapter was immediately switched off at the wall.A small spark was also observed coming from the pump.The pump was stopped and inspected.The users then found the melting located where the ac adapter and pump join.The pump was removed and a new pump was set up and started.

Manufacturer Narrative

Complaint pump was returned for evaluation.Electrical engineering department investigation found damage to the pwa in the pump indicating that an excessively high voltage was applied either through a voltage spike or damaged/incorrect ac adaptor which in turn, resulted in damage to the transient voltage supressor (tvs).The adaptor last plugged into the pump and sent back as part of the investigation was found to be working properly.Pump was damaged prior to the last ac adaptor being connected.Tvs diode for input voltage protection is located under the ac adaptor connector which was burned away and is believed to be the source of the heat.Root cause is believed to be a result of significant power of discharge in excess of 0.3j limit resulted in a shortage.The pump was still able to power on and run on battery power without issue.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): SMITHS MEDICAL, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5183897
• MDR Text Key: 29714750
• Report Number: 2183502-2015-00816
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2015

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 Catalogue Number: 21-2112-0300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/28/2015; 11/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1