MAUDE Adverse Event Report: COVIDIEN COVIDIEN; FEEDING TUBE

Model Number 775100

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 06/19/2014

Event Type  malfunction  

Event Description

The pump was beeping with a flow-pump error read.Nurse unplugged the pump from a white, non-generator outlet and plugged it into the red generator outlets to be certain it was not a power issue, in tandem with replacing the tube.After review, it s uncertain as to why the tubing was not working properly.The malfunctioning tubing was thrown out and replaced so we are unable to properly investigate the tubing itself.Tube feeding sets are covidien brand, model/mfg id 775100 and used with the kangaroo epump feeding pump.It is likely that all the lot number for the tube feeding during the malfunction was replaced with the same lot number tubing on that day.Correspondence with owens minor supplier, (b)(6), revealed that the lot numbers for the feeding sets are unable to be obtained.

• Brand Name: COVIDIEN
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; mansfield 02048
• MDR Report Key: 3961159
• MDR Text Key: 4557804
• Report Number: MW5037445
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2014

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 Model Number: 775100
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 103