QUANTUM PERFUSION DUAL LUMEN CANNULA DL27
Report
- Report Number
- 3016746283-2025-00009
- Event Type
- Malfunction
- Date Received
- September 29, 2025
- Date of Event
- August 29, 2025
- Report Date
- October 16, 2025
- Manufacturer
- SPECTRUM MEDICAL S.R.L.
- Product Code
- DWF
- UDI-DI
- 08051160300808
- PMA / PMN Number
- K221353
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DLF27-V0 DEVICE RETURNED FOR PERFORMANCE ISSUES. THE CANNULA WAS VISUALLY INSPECTED AND THEN TESTED TO VERIFY ITS PERFORMANCE. THE DATA COLLECTED SHOWS THAT THE DEVICE'S PRESSURE DROPS ARE COMPLIANT AND IN LINE WITH THE IFU. WITH THE AVAILABLE INFORMATION, WE WERE UNABLE TO IDENTIFY THE CAUSE OF THE PROBLEM LINKED TO THE MEDICAL DEVICE (REFER TO (B)(4)_INVESTIGATION_RMD FOR DETAILS).
ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER INVESTIGATION OF RETURNED DEVICE, WHICH WOULD BE ADDRESSED IN A FOLLOW-UP REPORT.
ON FRIDAY EVENING, CUSTOMER CALLED TO REPORT THAT EARLIER THAT DAY, THEY PLACED A PATIENT ON ECMO. THEY SELECTED THE QUANTUM 27FR DLC, BUT THEY WERE UNABLE TO FLOW. THE CUSTOMER REPORTED THAT THE CANNULA DID PRIME BACK WITH BLOOD, HOWEVER, WHEN THEY WENT TO CONNECT THE CANNULA TO THE CICUIT, THEY WERE UNABLE TO INITIATE AND ACHIEVE ANY FLOW. CUSTOMER REPORTED THAT THE ISSUE APPEARED TO BE ON THE DRAINAGE SIDE, AS THEY WERE NOT GETTING BLOOD BACK TO THE PUMP WHEN INITIATING AT 1500 RPMS OR WHEN SLOWLY INCREASING RPMS. DR. REDDY, THE CANNULATING SURGEON, HAD TO REMOVE THIS CANNULA, AND OVER WIRE TO EXCHANGE FOR A DIFFERENT ONE. THEY OPTED TO REPLACE OUR CANNULA WITH THE 29FR PROTEK DUO AND WERE ABLE TO SUCCESSFULLY DRAIN & FLOW TO THE PATIENT. THE CENTRIMAG CONSOLE AND PRECONNECTED PACK REMAINED THE SAME, THE ONLY CHANGE WAS THE CANNULA. THIS CUSTOMER DOES NOT MONITOR PRESSURES ON THEIR CENTRIMAG PACK, SO NONE TO REPORT. THE CUSTOMER DID SAVE THE CANNULA AND WOULD LIKE TO SEND IT BACK FOR INVESTIGATION. THE COORDINATOR, PERFUSIONIST AND SURGEON ALL VISUALLY INSPECTED THE CANNULA, BUT DID NOT SEE ANYTHING ABNORMAL.
ON FRIDAY EVENING, CUSTOMER CALLED TO REPORT THAT EARLIER THAT DAY, THEY PLACED A PATIENT ON ECMO. THEY SELECTED THE QUANTUM 27FR DLC, BUT THEY WERE UNABLE TO FLOW. THE CUSTOMER REPORTED THAT THE CANNULA DID PRIME BACK WITH BLOOD, HOWEVER, WHEN THEY WENT TO CONNECT THE CANNULA TO THE CICUIT, THEY WERE UNABLE TO INITIATE AND ACHIEVE ANY FLOW. CUSTOMER REPORTED THAT THE ISSUE APPEARED TO BE ON THE DRAINAGE SIDE, AS THEY WERE NOT GETTING BLOOD BACK TO THE PUMP WHEN INITIATING AT 1500 RPMS OR WHEN SLOWLY INCREASING RPMS. DR. REDDY, THE CANNULATING SURGEON, HAD TO REMOVE THIS CANNULA, AND OVER WIRE TO EXCHANGE FOR A DIFFERENT ONE. THEY OPTED TO REPLACE OUR CANNULA WITH THE 29FR PROTEK DUO AND WERE ABLE TO SUCCESSFULLY DRAIN & FLOW TO THE PATIENT. THE CENTRIMAG CONSOLE AND PRECONNECTED PACK REMAINED THE SAME, THE ONLY CHANGE WAS THE CANNULA. THIS CUSTOMER DOES NOT MONITOR PRESSURES ON THEIR CENTRIMAG PACK, SO NONE TO REPORT. THE CUSTOMER DID SAVE THE CANNULA AND WOULD LIKE TO SEND IT BACK FOR INVESTIGATION. THE COORDINATOR, PERFUSIONIST AND SURGEON ALL VISUALLY INSPECTED THE CANNULA, BUT DID NOT SEE ANYTHING ABNORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1773222 | QUANTUM PERFUSION DUAL LUMEN CANNULA DL27 | DUAL LUMEN CANNULA | DWF | SPECTRUM MEDICAL S.R.L. | DL27F-V0 | F000838 | 08051160300808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |