MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - NEW

Model Number 382400

Device Problem Insufficient Information (3190)

Patient Problem Vomiting (2144)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, an updated investigation will be provided.

Event Description

It was reported to medtronic on (b)(6) 2015 that the customer stated that the patient was overfed, which lead to vomiting and admittance to the hospital.

Manufacturer Narrative

(b)(4).An investigation of kangaroo epump for the reported condition of; the patient was overfed, which lead to vomiting and admittance to the hospital.Several attempts have been made to obtain the unit for evaluation.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.Product kangaroo epump was manufactured in 2013.A review of the device history record shows this device was released meeting all manufacturing specifications.Original information: manufacturer name: (b)(4).Original information: manufacturing facility name: (b)(4).

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: KANGAROO EPUMP
• 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: 5211934
• MDR Text Key: 31060212
• Report Number: 1282497-2015-00061
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2016
• 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): Other