FDA Adverse Event
Malfunction
Summary report: N
FLOPUMP
MDR report key: 11831716
·
Received May 17, 2021
Report
- Report Number
- 1645362-2021-00001
- Event Type
- Malfunction
- Date Received
- May 17, 2021
- Date of Event
- January 24, 2021
- Report Date
- May 28, 2021
- Manufacturer
- INTERNATIONAL BIOPHYSICS CORPORATION
- Product Code
- KFM
- PMA / PMN Number
- K170029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
PRODUCT WAS RECEIVED AND EVALUATED AND A SMALL LEAK WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem · 0
CUSTOMER OBSERVED LEAKING FROM THE CENTRIFUGE PUMP DURING THE PRIMING PROCEDURE. THERE WAS NO CONTACT WITH THE PATIENT, AND WAS REPLACED BEFORE THE PROCEDURE STARTED.
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT BEEN RETURNED. IF PRODUCT IS RETURNED OR ADDITIONAL INFOMRATION RECEIVED, A SUPPLEMENTAL REPORT SHALL BE SUBMITTED.
Description of Event or Problem · 1
CUSTOMER OBSERVED LEAKING FROM THE CENTRIFUGE PUMP DURING THE PRIMING PROCEDURE. THERE WAS NO CONTACT WITH THE PATIENT, AND WAS REPLACED BEFORE THE PROCEDURE STARTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735456 | FLOPUMP | FLOPUMP | KFM | INTERNATIONAL BIOPHYSICS CORPORATION | 120219-8253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |