MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/POLE CLMP; ENTERAL FEEDING PUMP

Model Number 383400

Device Problems Excess Flow or Over-Infusion (1311); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/21/2016.An investigation is currently underway.Upon completion, a full investigation will be provided.

Event Description

It was reported to covidien/medtronic on (b)(6) 2016 that the customer experienced an issue with an enteral feeding pump.The customer states that the unit is over-infusing and alarming.The customer states that the unit was set to a rate of 100ml/hr.After one hour of infusion, the volume that was infused was 114 ml.The customer does not know when the feed rate jumped.This even occurred during testing - water was used during this test.Epump 1000ml feeding set was used with the unit.The feeding set was used for 15 minutes prior to the test.There was no patient involvement.

Manufacturer Narrative

Investigation date: 07/18/2016.An investigation of kangaroo joey was performed for the reported condition of, ¿the customer states that the unit is over-infusing and alarming.The customer states that the unit was set to a rate of 100ml/hr.The customer states that after one hour of infusion, the volume that was infused was 114 ml.¿ initial testing of the unit found that the pump was functioning properly.The unit was escalated further testing, where it passed extended function, accuracy, and recertification.The reported condition could not be confirmed.Kangaroo joey was manufactured in 2012.A review of the device history record shows this device was released meeting all manufacturing specifications.(b)(6).

• Brand Name: KANGAROO JOEY,PUMP W/POLE CLMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5383718
• MDR Text Key: 36764347
• Report Number: 1282497-2016-00008
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

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: Other
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• 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