FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 4222854
·
Received August 6, 2014
Report
- Report Number
- 1828100-2014-00643
- Event Type
- Malfunction
- Date Received
- August 6, 2014
- Date of Event
- July 7, 2014
- Report Date
- July 14, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PER THE SUBSIDIARY SITE, THE EPGS SOFTWARE MODULE WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS A "SERVICE GAS SYSTEM" ERROR MESSAGE ON THE ELECTRONIC PATIENT GAS SYSTEM (EPGS). NO GAS LEAKS WERE OBSERVED. THE DEVICE WAS NOT CHANGED OUT, AS THEY USED A SPAR EXTERNAL GAS BLENDER. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THER WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460158 | TERUMO ADVANCED PERFUSION SYSTEM 1 | APS 1 (HEART LUNG CONSULE) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 801188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXTERNAL GAS BLENDER |