CARDIOQUIP MODULAR COOLER HEATER
Report
- Report Number
- 3007899424-2023-00183
- Event Type
- Malfunction
- Date Received
- June 23, 2023
- Date of Event
- May 29, 2023
- Report Date
- August 8, 2023
- Manufacturer
- CARDIOQUIP, LLC
- Product Code
- DWC
- PMA / PMN Number
- K102147
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
THE DEVICE WAS RETURNED TO SPECIFICATION VIA AN INTERNAL WATER PATHWAY REPLACEMENT. AFTER BEING REPAIRED, THE DEVICE PASSED INSPECTION AND IS FULLY FUNCTIONAL.
THE CUSTOMER NOTIFIED CARDIOQUIP THAT THEY ARE REQUESTING AN INTERNAL WATER PATHWAY REPLACEMENT FOLLOWING RECEIVING HPC TEST RESULTS OUTSIDE OF CARDIOQUIP'S SPECIFICATIONS.AS OF THE DATE OF THIS REPORT, THE DEVICE HAS BEEN RECEIVED AT CARDIOQUIP AND IS AWAITING SERVICE TO BE RETURNED TO SPECIFICATION.
WATER SAMPLES TAKEN BY THE CUSTOMER PRODUCED RESULTS OF 2760 MPN/ML, WHICH IS ABOVE THE ACCEPTABLE AMOUNT. BASED ON THE WATER LEVEL RESULTS, THE CUSTOMER HAS REQUESTED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THIS ISSUE WAS IDENTIFIED ON 05/29/2023, NO PATIENT INVOLVEMENT WAS REPORTED.
WATER SAMPLES TAKEN BY THE CUSTOMER PRODUCED RESULTS OF 2760 MPN/ML, WHICH IS ABOVE THE ACCEPTABLE AMOUNT. BASED ON THE WATER LEVEL RESULTS, THE CUSTOMER HAS REQUESTED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THIS ISSUE WAS IDENTIFIED ON (B)(6) 2023, NO PATIENT INVOLVEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1865597 | CARDIOQUIP MODULAR COOLER HEATER | CARDIOPULMONARY BYPASS DEVICE | DWC | CARDIOQUIP, LLC | MCH-1000(M) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |