FDA Adverse Event
Injury
Summary report: N
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
MDR report key: 4869409
·
Received June 24, 2015
Report
- Report Number
- 8010762-2015-00755
- Event Type
- Injury
- Date Received
- June 24, 2015
- Date of Event
- May 15, 2015
- Report Date
- May 15, 2015
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS INVESTIGATED BY A LOCAL MAQUET SERVICE TECHNICIAN. A DAMAGED RFC CONTROL BOARD WAS FOUND AND REPLACED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS.
Additional Manufacturer Narrative · 1
MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEVICE IN QUESTION WAS SENT BACK FOR INVESTIGATION. BUT THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL-MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
(B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 408326 | ROTAFLOW CENTRIFUGAL PUMP SYSTEM | KFM | MAQUET CARDIOPULMONARY AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |