MAUDE Adverse Event Report: MEDTRONIC-COVIDIEN KANGAROO PUMP

Device Problem Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2017

Event Type  Injury  

Event Description

Resident's feeding pump was alarming.G-tube was assessed for patency and was found to be patent.Resident sent to hospital ed for further evaluation and confirmation that tube was functioning correctly.G-tube confirmed patent, hospital suggests that feeding pump was malfunctioning.Resident returned to facility same day as event and attached to new feeding pump.No further issues.Difficulty contacting mfr initially as company has changed and contact was slow via email.Resident had previous visit to ed for g-tube related issues.Tube was found to have advanced into small bowel and required replacement.

• Brand Name: KANGAROO PUMP
• Type of Device: KANGAROO PUMP
• Manufacturer (Section D): MEDTRONIC-COVIDIEN
• MDR Report Key: 6575732
• MDR Text Key: 75545973
• Report Number: MW5069857
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Weight: 67