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

Model Number 382400

Device Problems Device Alarm System (1012); Display or Visual Feedback Problem (1184); Device Slipped (1584); Insufficient Flow or Under Infusion (2182); Defective Component (2292); Programming Issue (3014)

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

Event Date 08/21/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a feeding pump.The customer reports that the unit 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.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 reports when measuring the output from the feed and flush separately you will 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.Upon further clarification from the covidien, lead clinical product assurance analyst, the reported incident is more clearly described as, the customer notes that when the enteral pump is programmed to deliver a specific volume of enteral nutrition with a flush interval.The enteral volume displayed on the screen of the pump indicates that the programmed amount of enteral nutrition was delivered.The customer is finding that approximately half of the enteral nutrition and flush remain in the enteral feeding pump set.The customer attributes this issue to a bad pump valve selector.No patient involvement as issue identified during product testing within customer¿s biomedical engineering department.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.One kangaroo epump - new was returned to the service department with a specific request for service/repair.Initial testing of the unit found that the stopcock would spin in reverse when the rotor shaft would spin, causing the pump to pull fluid from both the feed bag and the flush bag when it should only pull from the feed, identifying a failure with the unit; therefore, this report will be considered confirmed.The pump gearbox was replaced and the pump was returned to the customer.Similar issues from samples from the same customer were investigated by covidien's r+d.It was concluded that lower than normal amounts of grease inside the gearbox housing and liquid ingress inside the gearbox caused the clutch components, which control the one way rotation of the gear shaft and which interface with the feeding set valve, to freeze causing the valve to turn in both directions.Product kangaroo epump - new was manufactured in 2013.A review of the service history records indicates there is no other service history recorded for this system.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer (Section G): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4115376
• MDR Text Key: 4923285
• Report Number: 3009247326-2014-00020
• 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: Invalid Data,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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