PROTEK DUO VENOUS CANNULA
Report
- Report Number
- 2531527-2025-20003
- Event Type
- Malfunction
- Date Received
- June 18, 2025
- Date of Event
- May 18, 2025
- Report Date
- August 11, 2025
- Manufacturer
- CARDIAC ASSIST INC.
- Product Code
- DWF
- PMA / PMN Number
- K140999
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. LOT NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE LOT NUMBER IS UNKNOWN, UNIQUE DEVICE IDENTIFIER (UDI) NUMBER AND EXPIRY DATE ARE NOT AVAILABLE. H.4. AS THE LOT NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H11: LIVANOVA MANUFACTURES THE PROTEK DUO CANNULA. THE INCIDENT OCCURRED IN BALTIMORE, MARYLAND. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
H11: AS ANTICIPATED IN THE PREVIOUS SUPPLEMENTAL REPORT, THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER LIVANOVA LEARNED THE FOLLOWING ADDITIONAL INFORMATION: - LOT NUMBER OF THE INVOLVED PRODUCT IS NOT AVAILABLE; - THE THROMBUS WAS LOCATED OUTFLOW, RETURN LIMB ONLY; ALSO A VIDEO WAS PROVIDED SHOWING CLOTTING IN THE OUTFLOW; - NO KINKING WAS OBSERVED; - ANTICOAGULATION PROTOCOL USED WAS SODIUM HEPARIN, TO TARGET PARTIAL THROMBOPLASTIN TIME (PTT) OF 45-60SEC. RISK OF DECANNULATION AND RECANNULATION WAS ACCEPTABLE GIVEN THE ACUTE THROMBUS. NO DEFECT OF THE CANNULA WAS IDENTIFIED THUS IT IS LIKELY THAT THE THROMBUS WAS DUE TO SPECIFIC BLOOD CONDITIONS AND ANTICOAGULANT THERAPY. A VIDEO WAS PROVIDED AND VISUAL INSPECTION CONFIRMED THAT BIOLOGICAL MATERIAL WAS INSIDE THE DISTAL TIP, CONFIRMING THE REPORTED ISSUE. FROM THE REVIEW OF THE DATABASE, NO CONCERNING TREND HAS BEEN IDENTIFIED. BASED ON ALL AVAILABLE INFORMATION, THE REPORTED ISSUE IS MOST LIKELY NOT DEVICE RELATED AND INSTEAD ASSOCIATED TO PATIENT CONDITIONS AND/OR TO INSUFFICIENT ANTICOAGULANT ADMINISTRATION. THE PROTEKDUO DIRECTIONS FOR USE (7000-0155 REV. A) CONTAINS THE FOLLOWING WARNING STATEMENT RELATED TO ANTICOAGULANT THERAPY: "THE ANTICOAGULATION REGIMEN EMPLOYED SHOULD BE BASED ON THE ACCEPTED GUIDELINES AND LOCAL BEST PRACTICES. GUIDELINES FROM THE EXTRACORPOREAL LIFE SUPPORT ORGANIZATION (ELSO) RECOMMEND AN INITIAL HEPARIN BOLUS OF 50-100 UNITS PER KG BODY WEIGHT AT THE TIME OF CANNULATION, SUBSEQUENTLY MAINTAINING AN ACT OF APPROXIMATELY 180 TO 220 SECONDS WITH CONTINUOUS HEPARIN INFUSION. (ELSO ANTICOAGULATION GUIDELINE (2014, AUGUST).¿ NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENT MONITORING IN ORDER TO EVALUATE ACTIONS FOR PRODUCT IMPROVEMENT. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.
LIVANOVA RECEIVED A REPORT RELATED TO ACUTE THROMBOSIS OF THE PROTEK DUO CANNULA 29FR ON DAY 11 (ELEVEN) OF PATIENT'S SUPPORT. IN DETAIL, FLOWS WENT FROM 2 LPM TO 0 LPM. PATIENT WAS THEN CONVERTED TO VA (VENOUS ARTERIAL) ECMO AND THE PROTEK DUO WAS REMOVED AND INSPECTED. A SIGNIFICANT THROMBUS WAS FOUND IN THE OUTFLOW LIMB. PATIENT WAS FULLY THERAPEUTIC FOR ANTICOAGULATION AT PTT (PARTIAL THROMBOPLASTIN TIME) >45 SECONDS. THERE WAS NO PATIENT INJURY.
SEE INITIAL REPORT.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353712 | PROTEK DUO VENOUS CANNULA | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | CARDIAC ASSIST INC. | PROTEK DUO ECLS CANNULA 29FR | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |