FDA Adverse Event
Malfunction
Summary report: N
PROMETRA PATIENT THERAPY CONTROLLER
MDR report key: 6064915
·
Received October 28, 2016
Report
- Report Number
- 3006803715-2016-00162
- Event Type
- Malfunction
- Date Received
- October 28, 2016
- Date of Event
- September 29, 2016
- Report Date
- September 29, 2016
- Manufacturer
- FLOWONIX MEDICAL, INC
- Product Code
- LKK
- PMA / PMN Number
- P080012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING AN APPOINTMENT ON (B)(6) 2016, IT WAS REPORTED THAT WHEN SETTING UP THE PATIENT THERAPY CONTROLLER (PTC), A BOLUS WAS DELIVERED WHEN THE NURSE WAS ATTEMPTING TO CONNECT THE PTC TO THE PUMP. IT WAS REPORTED THAT NO BUTTONS WERE PRESSED ON THE PTC THAT COULD HAVE LED TO THE DELIVERY OF THE BOLUS. THE BOLUS DELIVERY SCREEN WAS DISPLAYED, AND THE PTC STILL DID NOT CONNECT TO THE PUMP. TROUBLESHOOTING WAS NOT SUCCESSFUL. THE DEVICE WAS LEFT CHARGING OVERNIGHT, AND WAS SET UP SUCCESSFULLY ON THE FOLLOWING DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714760 | PROMETRA PATIENT THERAPY CONTROLLER | INFUSION PUMP PROGRAMMER | LKK | FLOWONIX MEDICAL, INC | 12860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |