FDA Adverse Event
Malfunction
Summary report: N
PATROL
MDR report key: 1912415
·
Received November 29, 2010
Report
- Report Number
- 1912415
- Event Type
- Malfunction
- Date Received
- November 29, 2010
- Date of Event
- November 26, 2010
- Report Date
- November 29, 2010
- Manufacturer
- ABBOTT NUTRITION (ROSS PRODUCTS)
- Product Code
- LZH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
Narratives
Description of Event or Problem · 1
THE PATIENT HAS A METABOLIC PROTEIN DEGRADATION PROBLEM AND CAME IN WITH HIGH AMMONIA LEVEL. SHE HAS CONTINUOUS G-TUBE FEEDS THAT HAVE A SPECIFIC AMOUNT OF PROTEIN AND PROTEIN SCAVENGERS. THE PUMP ALARMED "DOSE FED" AND THERE WAS STILL A LOT IN THE BAG. THE VOLUME WAS RESET TO INFUSE MORE AND IT BEEPED IN ANOTHER COUPLE OF HOURS, BUT THE VOLUME IN THE BAG REMAINED THE SAME. THE FEEDING TUBE WAS TAKEN APART AND THE PATIENT'S EXTENSION WAS FULLY CLOTTED. THE PUMP ONLY SAID "DOSE FED." THIS PUMP IS TO HAVE A "MALFUNCTION" STATEMENT, WHICH DID NOT ALARM OR NOTIFY STAFF. PATIENT REQUIRED MONITORING, BUT NO LONG-TERM ADVERSE OUTCOME TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATROL | PUMP, INFUSION, ENTERAL | LZH | ABBOTT NUTRITION (ROSS PRODUCTS) | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |