FDA Adverse Event
Malfunction
Summary report: N
PATROL PUMP
MDR report key: 863953
·
Received June 11, 2007
Report
- Report Number
- 1528738-2007-00068
- Event Type
- Malfunction
- Date Received
- June 11, 2007
- Report Date
- May 24, 2007
- Manufacturer
- ROSS PRODUCTS DIVISION
- Product Code
- LZH
- PMA / PMN Number
- K943733
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO TESTING AND INVESTIGATION RESULTS HAVE BEEN RECEIVED.
Description of Event or Problem · 1
THERE WAS NO REPORT OF SERIOUS INJURY OR ILLNESS ASSOCIATED WITH THIS COMPLAINT. A PRODUCT PROBLEM HAS BEEN REPORTED TO BE ASSOCIATED WITH THIS COMPLAINT, DELIVERY OF 900 ML RATHER THAN THE 520 ML INTENDED (DELIVERY TIME UNREPORTED) USING THE PATROL PUMP LIST #52034 (73% OVER-DELIVERY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATROL PUMP | 80 LZH PUMPS, INFUSION, ENTERAL | LZH | ROSS PRODUCTS DIVISION | 52036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR |