FDA Adverse Event
Malfunction
Summary report: N
HL-20 INTEGRATED PERFUSION SYSTEM
MDR report key: 6185305
·
Received December 19, 2016
Report
- Report Number
- 8010762-2016-00723
- Event Type
- Malfunction
- Date Received
- December 19, 2016
- Date of Event
- November 28, 2016
- Report Date
- January 12, 2017
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K943803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT # WAS INCORRECTLY REPORTED AS (B)(4) AND SHOULD HAVE BEEN REPORTED AS (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 1
FIELD SAFETY ENGINEER HAS BEEN SENT FOR INVESTIGATION AND FOUND DEFECTIVE PUMP CONTROL BOARD. THE DEFECTIVE PUMP CONTROL BOARD WAS REPLACED AND DEVICE WORKED AS IT SHOULD. THUS THE FAILURE COULD BE CONFIRMED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.
Description of Event or Problem · 1
(B)(4).
Description of Event or Problem · 1
IT WAS STATED THAT DURING STARTUP PF THE DEVICE AN "SAFETY-S" ERROR OCCURRED ON THE RPM. (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 835606 | HL-20 INTEGRATED PERFUSION SYSTEM | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY AG | MCP00703761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |