FDA Adverse Event
Malfunction
Summary report: N
CARDIOQUIP MODULAR COOLER HEATER
MDR report key: 14745040
·
Received June 20, 2022
Report
- Report Number
- 3007899424-2022-00022
- Event Type
- Malfunction
- Date Received
- June 20, 2022
- Date of Event
- December 20, 2021
- Report Date
- May 31, 2022
- Manufacturer
- CARDIOQUIP, LLC
- Product Code
- DWC
- PMA / PMN Number
- K102147
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER IS REPORTING THE FOLLOWING COMPLAINT AFTER A VOLUNTARY REVIEW OF ALL COMPLAINTS (REPORTABLE OR NOT) SINCE 2016. THIS REPORT IS BEING FILED NOW, AFTER BEING SCRUTINIZED UNDER A NEWLY REVISED RISK MATRIX, RECENTLY ADOPTED AFTER INSPECTION. THE CUSTOMER SUSPECTED THAT A FEW DEVICES HAVE BIOFILM GROWTH IN THE INTERNAL TUBING. CARDIOQUIP RECOMMENDED AN INTERNAL WATER PATH REPLACEMENT. THE DEVICE WAS SENT IN FOR INTERNAL WATER PATH REPLACEMENT AND TESTED PRIOR AND POST REPLACEMENT. THE CFU COUNT WAS WITHIN THE ACCEPTABLE LEVEL POST REPLACEMENT.
Description of Event or Problem · 0
CUSTOMER REPORTED SUSPECTED BIOFILM IN THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1847253 | CARDIOQUIP MODULAR COOLER HEATER | CARDIOPULMONARY BYPASS DEVICE | DWC | CARDIOQUIP, LLC | MCH-1000(I) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |