FDA Adverse Event
Malfunction
Summary report: N
TERUMO PERFUSION SYSTEM 8000
MDR report key: 3012848
·
Received February 5, 2013
Report
- Report Number
- 1828100-2013-00088
- Event Type
- Malfunction
- Date Received
- February 5, 2013
- Date of Event
- January 12, 2013
- Report Date
- January 12, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K915183
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED.
Description of Event or Problem · 1
THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, WAS UNABLE TO RESET THE LEVEL SENSOR ALARM (RED). ON SETTINGS 1 AND 2 THE FLUID WAS ABOVE THE SENSOR ON SAFETY MONITOR. THE SAFETY MONITOR ONLY OPERATED ON SETTING 4 ALERT (YELLOW). THE CUSTOMER IS USING SETTING 4 (ALERT ONLY) UNTIL THEY GET THE NEW REPLACEMENT MONITOR. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49936 | TERUMO PERFUSION SYSTEM 8000 | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 16404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |