FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 3901785
·
Received May 8, 2014
Report
- Report Number
- 1828100-2014-00344
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- April 10, 2014
- Report Date
- April 17, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00342 AND MDR #1828100-2014-00343.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, "MOSAIC" LIKE LINES APPEARED ON THE SCREEN WHEN STARTING THE CENTRAL CONTROL MONITOR (CCM). AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279729 | TERUMO ADVANCED PERFUSION SYSTEM 1 | APS 1 (CCM) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 802100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |