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

Model Number 382400

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Pneumonia (2011); Vomiting (2144); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to covidien on 05/04/2016 that a customer had an issue with an enteral feeding pump.The customer states that they set the feed rate on the pump to 400ml instead of 40ml.The patient was overfeed as a result.The patient experienced vomiting and an aspiration pneumonia which required the patient to be transferred to a higher level of care.A rapid response was called and the patient was transferred.The patient was ultimately discharged from the facility.

Manufacturer Narrative

Submit date: 10/24/2016.An investigation kangaroo epump was performed for the reported condition of; the unit was set to feed 400ml instead of 40ml.The patient was overfed as a result.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.The device history record could not be reviewed as the unit¿s serial number could not be provided.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.

• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5656655
• MDR Text Key: 45233507
• Report Number: 1282497-2016-00210
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention