FDA Adverse Event
Malfunction
Summary report: N
CARDIOQUIP MODULAR COOLER HEATER
MDR report key: 14781531
·
Received June 22, 2022
Report
- Report Number
- 3007899424-2022-00028
- Event Type
- Malfunction
- Date Received
- June 22, 2022
- Date of Event
- September 28, 2021
- Report Date
- June 3, 2022
- Manufacturer
- CARDIOQUIP, LLC
- Product Code
- DWC
- PMA / PMN Number
- K102147
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 REPORTS THEY BELIEVE THE UNIT TO BE CONTAMINATED WITH BACTERIA. THE DEVICE RECEIVED, WAS TESTED, AND FOUND THAT IT WAS CONTAMINATED. CARDIOQUIP PERFORMED AN INTERNAL WATER PATH REPLACEMENT AND TESTED POST PROCEDURE AND FOUND IT TO BE IN ACCEPTABLE LIMITS.
Description of Event or Problem · 0
CUSTOMER REPORTS CONTAMINATED EXTERNAL TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1239551 | CARDIOQUIP MODULAR COOLER HEATER | CARDIOPULMONARY BYPASS DEVICE | DWC | CARDIOQUIP, LLC | MCH-1000 (I) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |