FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 3101709
·
Received May 3, 2013
Report
- Report Number
- 1828100-2013-00416
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 9, 2013
- Report Date
- April 12, 2013
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEM 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
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED PER THE SUBSIDIARY MANUFACTURING ENGINEERING CENTER (MEC), THIS ISSUE COULD BE DUPLICATED. "PAUSED (CANNOT FIX) ..." ERROR MESSAGE WAS DISPLAYED ON CCM.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DID NOT POWER ON AND A "SYSTEM COMPUTER NEEDS SERVICE" ERROR MESSAGE WAS DISPLAYED ON CCM. THE DEVICE WAS NOT CHANGED OUT, THE USER CONTINUED TO USE ROLLER PUMP LOCAL CONTROLS AND AS A SUCKER PUMP. THEY USED AN ALTERNATE MANUFACTURER'S PUMP AS MAIN PUMP. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND 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 |
|---|---|---|---|---|---|---|---|
| 195017 | TERUMO ADVANCED PERFUSION SYSTEM 1 | DTQ | TERUMO CARDIOVASCULAR SYSTEM CORP | 802100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |