FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2210275
·
Received August 8, 2011
Report
- Report Number
- 1828100-2011-02377
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 14, 2011
- Report Date
- August 8, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE FIELD SERVICE REP REPORTED THAT THERE WAS A CRACK ON THE DOME OF THE WATER TRAP ASSEMBLY. THE WATER TRAP ASSEMBLY WAS REPLACED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | HEART LUNG CONSOL GAS MODULE | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP | 801188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |