FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 4172367
·
Received October 9, 2014
Report
- Report Number
- 1828100-2014-00855
- Event Type
- Malfunction
- Date Received
- October 9, 2014
- Date of Event
- September 16, 2014
- Report Date
- September 16, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
THE FIELD SVC REP (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, A SPARE OCCLUDER HEAD HAD A BROKEN END COVER ASSEMBLY. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636806 | TERUMO ADVANCED PERFUSION SYSTEM 1 | APS 1 (HEART LUNG CONSOLE) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 806455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |