FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1062285
·
Received June 18, 2008
Report
- Report Number
- 1828100-2008-00309
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- May 15, 2008
- Report Date
- June 18, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT CONCLUDED.
Description of Event or Problem · 1
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE SYSTEM SHUT DOWN UNEXPECTEDLY FOR APPROX 30 SECONDS AND THEN REBOOTED AUTOMATICALLY. THE USER PROCEEDED WITH THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | HEART LUNG CONSOLE (CIRCUIT BREAKER) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |