FDA Adverse Event
Injury
Summary report: N
MAQUET CARDIOHELP
MDR report key: 4122374
·
Received September 18, 2014
Report
- Report Number
- 8010762-2014-00331
- Event Type
- Injury
- Date Received
- September 18, 2014
- Date of Event
- February 10, 2014
- Report Date
- February 26, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K102726
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE LOG FILES WERE EVALUATED AND SHOW THE USER HAD EXPERIENCED SEVERAL BUBBLE DETECTION ALARMS OVER A FIVE MINUTE PERIOD. IF THE BUBBLE INTERVENTION WAS SET, THIS CAUSE THE PUMP TO STOP TO PREVENT AIR FROM INFILTRATING THE PATIENT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ERROR MESSAGE 1PM INEFFICIENT NO FLOW APPEARED WHILE THE PUMP WAS RUNNING AT 3500RPM. THE PUMP STOPPED AND THE EMERGENCY DRIVE WAS USED. THE UNIT WAS REPLACED. NO PATIENT HARM WAS REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579082 | MAQUET CARDIOHELP | CARDIOHELP | DTQ | MAQUET CARDIOPULMONARY AG | 70104.8012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |