FDA Adverse Event
Summary report: N
FLECK CONTROL HEADS
MDR report key: 1171624
·
Received September 12, 2008
Report
- Report Number
- 1171624
- Date Received
- September 12, 2008
- Date of Event
- August 12, 2008
- Report Date
- September 12, 2008
- Manufacturer
- PENTAIR - HOME OF FLECK
- Product Code
- FIP
- Report Source
- User Facility report
- Reporter Location
- WY, US
Narratives
Description of Event or Problem · 1
IN OUR DIALYSIS UNIT WE HAVE 4 FLECK HEADS MOUNTED ON TANKS FOR A MULTIMEDIA FILTER, A WATER SOFTENER, AND 2 CARBON TANKS THAT TREAT OUR INCOMING WATER BEFORE IT ENTERS THE RO SYSTEM. DURING A THREE WEEK PERIOD, THREE OF THE PISTONS INSIDE OF THE FLECK HEADS BROKE OFF OF THE PISTON SHAFT AND BECAME STUCK; ALL THREE WERE PUSHED IN FULLY WHEN THE BREAK OCCURRED. THIS INTERRUPTED DIALYSIS WHEN THE PISTON FOR THE CARBON TANK BROKE, AND PATIENTS WERE DIVERTED TO ANOTHER FACILITY UNTIL REPLACEMENT PARTS WERE OBTAINED AND INSTALLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLECK CONTROL HEADS | CONTROL VALVE, RO | FIP | PENTAIR - HOME OF FLECK | 2850 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NO OTHER THERAPIES| NO OTHER THERAPIES |