FDA Adverse Event
Malfunction
Summary report: N
CLEARSTAR
MDR report key: 3678977
·
Received March 14, 2014
Report
- Report Number
- 1527460-2014-00002
- Event Type
- Malfunction
- Date Received
- March 14, 2014
- Date of Event
- February 13, 2014
- Report Date
- February 13, 2014
- Manufacturer
- FRANTZ MEDICAL DEVELOPMENT LTD.
- Product Code
- LZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE REPORTED, LIST NUMBER M771, IS AN ABBOTT PRODUCT THAT IS MARKED INTERNATIONALLY, WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 55239, THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN INFORMATION FROM THE SOURCE.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED AN UNDER DELIVERY. THE PUMP ONLY DELIVERED 250 ML OF PRODUCT IN SEVEN HOURS WITH THE RATE SET AT 60 ML AN HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153915 | CLEARSTAR | LZH | FRANTZ MEDICAL DEVELOPMENT LTD. | 20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |