QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGR
Report
- Report Number
- 3016746283-2025-00008
- Event Type
- Malfunction
- Date Received
- September 11, 2025
- Date of Event
- August 12, 2025
- Report Date
- October 16, 2025
- Manufacturer
- SPECTRUM MEDICAL S.R.L.
- Product Code
- KFM
- UDI-DI
- 08051160300624
- PMA / PMN Number
- K201320
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE ANALYSIS REVEALED THAT A PIN IN THE INLET SENSOR IS BENT, CAUSING THE IMPOSSIBILITY TO READ THE PRESSURE VALUE. RECORDS OF THE ANALYSES CARRIED OUT IN THE CLEAN ROOM BEFORE DEVICE'S RELEASE, REVEALED THAT THE TWO SENSORS PERFORMED CORRECTLY WHEN TESTED. SINCE THE DEVICE PASSED THIS CONTROL, IT CAN BE ASSUMED THAT THE PIN WAS DAMAGED DURING CLINICAL PROCEDURE (REFER TO BHCX763_INVESTIGATION_RMD).
ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER INVESTIGATION OF RETURNED DEVICE, WHICH COULD BE ADDRESSED IN A FOLLOW-UP REPORT.
CP22 DISPOSABLE PORT ON THE INLET SIDE APPEARS TO HAVE CUT OUT DURING THE RUN. PERFUSIONIST STATES THAT THE INLET PRESSURE DECREASED TO -700, CAUSING THE PUMP TO STOP BEFORE THE INLET PRESSURE IN THE GUAGE BAR WENT COMPLETELY BLANK.
CP22 DISPOSABLE PORT ON THE INLET SIDE APPEARS TO HAVE CUT OUT DURING THE RUN. PERFUSIONIST STATES THAT THE INLET PRESSURE DECREASED TO -700, CAUSING THE PUMP TO STOP BEFORE THE INLET PRESSURE IN THE GUAGE BAR WENT COMPLETELY BLANK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2231777 | QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGR | CENTRIFUGAL BLOOD PUMP | KFM | SPECTRUM MEDICAL S.R.L. | CP22V-VT | H000145 | 08051160300624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |