FDA Adverse Event
Malfunction
Summary report: N
CLEARSTAR PUMP
MDR report key: 3795647
·
Received May 7, 2014
Report
- Report Number
- 9610175-2014-00009
- Event Type
- Malfunction
- Date Received
- May 7, 2014
- Report Date
- April 8, 2014
- Manufacturer
- FRANTZ MEDICAL DEVELOPMENT LTD.
- Product Code
- LZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REPORTED: LIST NUMBER M771, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY, WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 55239, THAT IS MARKETED DOMESTICALLY.
Additional Manufacturer Narrative · 1
MANUFACTURER EVENT ID#: (B)(6). THE UK AFFILIATE ATTEMPTED FOUR TIMES TO HAVE THE PUMP UPLIFTED AND RETURNED TO ABBOTT FOR PRODUCT EVALUATION.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED AN OVER DELIVERY. THE INTENDED DELIVERY WAS 300 ML AT 33 ML/HOUR FOR NINE (9) HOURS BUT COMPLAINANT RECEIVED HIS ENTERAL FEED IN SIX (6) HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 275783 | CLEARSTAR PUMP | PUMP, INFUSION, ENTERAL | LZH | FRANTZ MEDICAL DEVELOPMENT LTD. | 20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 MO |