MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO EPUMP - NEW; FEEDING PUMP

Model Number 382400

Device Problems Device Alarm System (1012); Device Slipped (1584); Failure to Deliver (2338)

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

Event Date 04/21/2014

Event Type  Other  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a feeding pump.The customer reports that the pump has a bad valve selector that just spins in circles rather than selecting the flush or feed line and there is no alarm when this occurs, the pump continues to operate.The customer states that after the set amount of fluid is delivered on a feed only setting, the pump tells the user that it delivered the correct amount.The customer also states that the volume the pump delivers is correct but when they measure the output from the feed and flush separately, they find that even though the pump was set to feed, if the valve is bad, it delivers almost exactly half the volume from the feed and the flush without ever alerting the user that there is an issue.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): JABIL SINGAPORE; 16 tampines industrial c; singapore ; SG
• Manufacturer (Section G): JABIL SINGAPORE; 16 tampines industrial crescent; singapore ; SG
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3844689
• MDR Text Key: 4658679
• Report Number: 3009247326-2014-00009
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 05/15/2014
• Date Manufacturer Received: 04/28/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1