FDA Adverse Event
Malfunction
Summary report: N
KANGAROO EPUMP - NEW
MDR report key: 5816093
·
Received July 22, 2016
Report
- Report Number
- 1282497-2016-00530
- Event Type
- Malfunction
- Date Received
- July 22, 2016
- Report Date
- May 30, 2016
- Manufacturer
- COVIDIEN
- Product Code
- LZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, A FULL REPORT SHALL BE PROVIDED.
Additional Manufacturer Narrative · 1
SUBMIT DATE: 03/08/02017. AN EVALUATION OF THE KANGAROO EPUMP WAS PERFORMED FOR THE REPORTED CONDITION OF THE UNIT UNDER INFUSING. THE UNIT WAS TRIAGED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE UNIT PASSED ALL TESTING. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THIS UNIT WAS MANUFACTURED IN 2012 AND WAS RELEASED MEETING ALL MANUFACTURING SPECIFICATIONS. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 5/30/2016 THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN ENTERAL FEEDING PUMP. THE CUSTOMER STATES THE UNIT IS UNDER INFUSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470699 | KANGAROO EPUMP - NEW | ENTERAL FEEDING PUMP | LZH | COVIDIEN | 382400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |