MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO JOEY,PUMP W/POLE CLMP; FEEDING PUMP

Model Number 383400

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 02/26/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 detective (b)(6) at (b)(6) sheriff¿s department called requesting information on 3 kangaroo joey feeding pumps, serial numbers (b)(4), found at the home of a deceased patient.The beaufort county sheriff's¿s department is investigating the death of a (b)(6) year old boy who passed away on (b)(6) 2015.The detective stated that he is unable to provide any additional information regarding this event as there is an ongoing investigation but the detective did state; he did not believe the covidien machines were related to this event.This is one of three reports for a single event.

Manufacturer Narrative

Submit date: 03/04/2015.An investigation is currently underway; upon completion, the results will be forwarded.

Manufacturer Narrative

To date, the service department has not received a sample for evaluation.Without the sample, a detailed investigation could not be performed and the reported condition of (b)(6) called requesting information on 3 feeding pumps found at the home of a deceased patient.The sherriff is investigating the death of a (b)(6) boy who passed away on (b)(6) 2015.The sheriff found 3 kangaroo joey feeding pumps in the deceased home, could not be confirmed.Without a sample to investigate, no actual root cause can be determined.Kangaroo joey,pump w/clmp was manufactured in 2013.This file will be closed as unconfirmed at this time.If additional information is obtained, or the sample is returned to the service department, we will re-open this investigation.

• Brand Name: KANGAROO JOEY,PUMP W/POLE CLMP
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer (Section G): JABIL SINGAPORE; 6 tampines industrial crecsent; singapore ; SN
• Manufacturer Contact: natasha soares ; 15 hampshire street; mansfield, MA 02048 ; 5084521608
• MDR Report Key: 4570916
• MDR Text Key: 5462562
• Report Number: 1282497-2015-00010
• 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: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Device Lot Number: F13016270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other