FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 3241129
·
Received July 18, 2013
Report
- Report Number
- 1828100-2013-00677
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 27, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SOFTWARE DATA LOGS WERE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION ON (B)(4) 2013.
Description of Event or Problem · 1
IT WAS REPORTED BY THE SUBSIDIARY ASSOCIATE THAT A PUMP JAM OCCURRED ON THE CARDIOPLEGIA ROLLER PUMP. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336409 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEM CORP. | 801040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |