FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 4213137
·
Received August 4, 2014
Report
- Report Number
- 1828100-2014-00675
- Event Type
- Malfunction
- Date Received
- August 4, 2014
- Date of Event
- July 10, 2014
- Report Date
- July 10, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00561. THE CUSTOMER HAD PUT ON A NEW FLOW SENSOR TO REPLACE THE SUSPECT SENSOR. THE FSR BELIEVES THAT THE CUSTOMER BENT THE PINS WHEN THEY INSTALLED THE NEW FLOW SENSOR.
Description of Event or Problem · 1
THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING REPAIR OF THE DEVICE ON COMPLAINT MDR #1828100-2014-00561, HE FOUND THE FLOW SENSOR HAD A BENT PIN. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455650 | TERUMO ADVANCED PERFUSION SYSTEM 1 | APS 1 (HEART LUNG CONSOLE) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 6382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |