MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - NEW; ENTERAL FEEDING PUMP

Model Number 382400

Device Problems Failure to Advance (2524); Device Displays Incorrect Message (2591)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

Submit date: 07/08/2016.An investigation is currently underway.Upon completion, a full report shall be provided.Medwatch report #: mw5062608.

Event Description

It was reported to covidien on 06/29/2016 that the customer experienced an issue with an enteral feeding pump.The customer states the unit's alarm was manually turned off.The pump does not have an indicator to show when the alarm is silenced on the main screen; nurse wasn't aware pump was silenced by previous user.The pump did not produce an audible alarm when an error occurred.The unit was set to feed 17mls/hr.After two hours of feeding the nurse checked on the patient and noticed the pump was not running.The entire feed was still in the bag.The patient's glucose level was low, so an iv was started and dextrose bolus was given.Unit was abated after use.

Manufacturer Narrative

To date, the unit has not been received for evaluation.Without the unit, a detailed investigation could not be performed and the reported condition could not be confirmed.This complaint file shall be closed as unconfirmed at this time.If the unit is returned, the complaint shall be re-opened.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5778949
• MDR Text Key: 49068838
• Report Number: 1282497-2016-00429
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: 06/29/2016
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other