MAUDE Adverse Event Report: COVIDIEN; PUMP, INFUSION, ENTERAL

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer stated the patient was on multiple iv infusions and a tube feeding, which was being delivered via pump.Clear iv fluid dripped on to the tube feeding power supply where the pump plugs in.The fluids dripping on the electrical connection of the feeding pumps electrical connector shorted out the connector, causing it to burst into flames.The equipment was evaluated by the facilities biomed department.They believed there was no issue with the pump and the cause was "user error" in allowing fluid to drip onto the equipment.The pump was returned to service.

• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9197952
• MDR Text Key: 162498860
• Report Number: 1282497-2019-08717
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1