FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 2211818
·
Received August 10, 2011
Report
- Report Number
- 1828100-2011-02395
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- June 30, 2011
- Report Date
- August 10, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Removal / Correction Number
- AA-2011-006-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE DEVICE MEMBRANE WAS BROKEN. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES 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 | PRESSURE MONITORING KIT | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 16066100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |