HLS CANNULA + PIK
Report
- Report Number
- 8010762-2024-0000499
- Event Type
- Injury
- Date Received
- October 21, 2024
- Date of Event
- September 30, 2024
- Report Date
- April 24, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DWF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NEW INFORMATION WAS RECEIVED ON (B)(6) 2024 AS THE FAILURE 'AIR EMBOLISM' HAD OCCURRED ON VENOUS CANNULA THEREFORE PRODUCT INFORMATION WAS UPDATED. FURTHER, CUSTOMER REPLACED THE CANNULA DURING TREATMENT AND AFTER REPLACEMENT NO AIR BUBBLES OCCURRED AGAIN. IT WAS REPORTED THAT THE REPLACED CANNULA SHOWS LONGITUDINAL INCISION. DESCRIPTION OF EVENT HAS BEEN UPDATED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
THE EVENT OCCURRED IN GERMANY. GETINGE RECEIVED AN AUTHORITY REPORT FROM BFARM ON 2024-10-01 AND THE FOLLOWING WAS REPORTED: AT AROUND 9:54 A.M ON 2024-09-30, AIR EMBOLISMS WERE VISIBLE IN THE PATIENT'S LEFT VENTRICLE IN THE TEE. THESE WOULD DISAPPEAR AS SOON AS THE CARDIOHELP CONSOLE WAS TURNED OFF. THE CARDIOHELP AND THE HLS MODULE WAS IMMEDIATELY REPLACED, WHICH MEANT THAT THE AIR EMBOLISMS IN THE LEFT VENTRICLE NO LONGER OCCURRED. A COMPLAINT WAS OPENED IN ONETRACK SYSTEM WITH NUMBER #(B)(4) MFG REPORT #8010762-2024-0000480. DURING THE INVESTIGATION OF THE COMPLAINT #(B)(4) A NEW INFORMATION WAS RECEIVED ON 2024-10-16 AS A SECOND AIR EMBOLISM WAS OCCURRED ON THE SYSTEM. THE SECOND AIR EMBOLISM WAS AT THE VENOUS CANNULA AND CUSTOMER REPLACED THE PRODUCT DURING TREATMENT. AFTER REPLACEMENT, THE FAILURE WAS NOT OCCURRED AGAIN. IT WAS REPORTED THAT THE REPLACED CANNULA SHOWS LONGITUDINAL INCISION. THE SAMPLE WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON 2024-12-16. VISUAL INSPECTION SHOWS A CRACK ON HLS CANNULA CONNECTOR. FURTHER, SCRATCHES WERE OBSERVED ON CONNECTOR. ADHESIVE RESIDUES WERE FOUND ON THE HLS CANNULA BODY, AND THE PRODUCT MARKS WERE FOUND AS REMOVED. LEAKAGE TEST WAS PERFORMED AND AIR BUBBLES AT THE CRACK OF THE CONNECTOR WAS SEEN. BASED ON THESE, A CRACK ON THE CONNECTOR COULD BE CONFIRMED, HOWEVER THERE COULD NOT BE FOUND ANY NON-CONFORMITIES THAT INDICATES PRODUCT FAILURE. GETINGE MEDICAL AFFAIRS CONDUCTED A MEDICAL REVIEW ON 2025-04-11. TWO AIR EMBOLISM EVENTS OCCURRED DURING THE USE OF GETINGE¿S HLS/PLS ECMO SYSTEMS IN COMBINATION WITH AN IMPELLA CP DEVICE. THE FIRST EVENT SHOWED AIR IN THE LEFT VENTRICLE, WHICH DISAPPEARED WHEN THE CARDIOHELP SYSTEM WAS TURNED OFF. THE SYSTEM WAS REPLACED, BUT THE CANNULAS REMAINED IN PLACE. LATER, AIR WAS SEEN IN THE VENOUS CANNULA, PROMPTING ANOTHER REPLACEMENT. A SCALPEL HAD LIKELY DAMAGED THE CANNULA CONNECTOR DURING THE SET CHANGE, CAUSING A LONGITUDINAL CUT AND EVENTUAL AIR ENTRY. OPERATIONALLY, HIGH BLOOD FLOW RATES (>5 L/MIN) AND STRONG NEGATIVE SUCTION PRESSURE (< -140 MMHG) MAY HAVE CAUSED CAVITATION (GAS BUBBLE FORMATION) ON THE VENOUS SIDE. THE CARDIOHELP¿S BUBBLE SENSOR DIDN¿T DETECT ARTERIAL AIR, SUGGESTING THE ISSUE WAS ON THE VENOUS SIDE OR DUE TO HEMODYNAMIC FACTORS RATHER THAN PRODUCT FAILURE. TESTING SHOWED NO DEFECTS IN THE HLS SET ITSELF, BUT THE CANNULA DAMAGE WAS CONFIRMED AS A LIKELY SOURCE OF THE SECOND AIR INGRESS. THE REVIEW INVESTIGATED TWO AIR EMBOLISM EVENTS DURING ECMO THERAPY USING THE GETINGE HLS/PLS OXYGENATION SYSTEMS AND AN IMPELLA CP DEVICE. THESE EVENTS APPEARED TO HAVE DIFFERENT BUT INTERCONNECTED CAUSES: 1. FIRST AIR EMBOLISM EVENT (LEFT VENTRICLE): - OCCURRED UNDER EXTREME OPERATING CONDITIONS: BLOOD FLOW > 5 L/MIN AND VENOUS SUCTION PRESSURES < -140 MMHG. - NO AIR WAS DETECTED IN THE ARTERIAL LINE BY THE SYSTEM¿S BUBBLE SENSOR, BUT AIR WAS SEEN IN THE LEFT VENTRICLE (LV). - THE LIKELY CAUSE WAS CAVITATION OR OUTGASSING¿GAS BUBBLES FORMING DUE TO HIGH NEGATIVE PRESSURE¿NOT A PRODUCT DEFECT. - LITERATURE SUPPORTS THAT HIGH SUCTION CAN CAUSE GAS BUBBLES TO FORM IN ECMO SYSTEMS. 2. SECOND AIR EMBOLISM EVENT (VENOUS CANNULA): - CAUSED BY MECHANICAL DAMAGE: DURING A TUBING CHANGE, THE CANNULA CONNECTOR WAS CUT WITH A SCALPEL, RESULTING IN A SMALL INCISION. - INITIALLY, THE TUBING LIKELY COVERED THE DAMAGE, BUT OVER TIME, LOOSENING OR THERMAL EFFECTS ALLOWED AIR TO ENTER. - CONFIRMED VISUALLY AND ACKNOWLEDGED BY THE USER. ONCE THE CANNULA WAS REPLACED, THE PROBLEM STOPPED. - THE INSTRUCTIONS FOR USE (IFU) SPECIFICALLY WARN AGAINST THIS TYPE OF HANDLING (I.E., CUTTING NEAR REINFORCED AREAS). 3. PRODUCT INVESTIGATION FINDINGS: - NO FAULTS OR LEAKS WERE FOUND IN THE RETURNED HLS SETS. - THE BUBBLE FORMATION WAS NOT REPRODUCIBLE UNDER LAB CONDITIONS. - THE PRODUCT FUNCTIONED CORRECTLY, RULING OUT A DEVICE MALFUNCTION. 4. ADDITIONAL CONSIDERATIONS: - THE USE OF IMPELLA CP MAY HAVE CONTRIBUTED TO THE AIR EMBOLISM, ESPECIALLY IF AIR ENTERED LOCALLY (E.G., VIA PURGE SYSTEM) RATHER THAN MIGRATING FROM THE VENOUS CIRCUIT. - COMPLEX FLOW DYNAMICS BETWEEN ECMO AND IMPELLA SYSTEMS CAN CREATE CONDITIONS FOR AIR TO ACCUMULATE IN THE HEART, PARTICULARLY THE LV. 5. PATIENT OUTCOME: - THE PATIENT HAD A COMPLICATED HISTORY (INCLUDING PRIOR CARDIAC SURGERIES). - AFTER THE EMBOLISM EVENTS, CT SCANS SHOWED MULTIPLE EMBOLIC INFARCTIONS, CONSISTENT WITH SYSTEMIC AIR EMBOLISM. BASED ON THE PERFORMED EVALUATION, NO DESIGN OR MANUFACTURING FAULT WAS FOUND IN THE MEDICAL DEVICES. THE FIRST EMBOLISM LIKELY RESULTED FROM EXTREME USAGE CONDITIONS (HIGH SUCTION/FLOW), AND THE SECOND FROM USER-RELATED MECHANICAL DAMAGE. THIS CASE HIGHLIGHTS THE IMPORTANCE OF PROPER HANDLING TECHNIQUES AND AWARENESS OF HEMODYNAMIC FACTORS WHEN USING COMPLEX SYSTEMS LIKE ECMO WITH IMPELLA. FURTHERMORE, THE RELATED BELOW IFU MITIGATIONS WERE STATED WITHIN THE MEDICAL REVIEW: - CAUTION!: IF A SUTURE IS DIRECTLY LOOPED AROUND THE WIRE-REINFORCED SECTION, THE CANNULA CAN BE CUT INTO, KINKED OR DAMAGED. SECURE THE CANNULA AROUND THE RIGID BARBED CONNECTORS IN SUCH A WAY AS TO ENSURE THAT IT IS NOT KINKED AT THE INSERTION SITE. - CAUTION!: ATTACH THE CANNULA SECURELY TO THE VESSEL OR SURROUNDING TISSUE TO PREVENT ACCIDENTAL DISLOCATION DURING THE EXTRACORPOREAL CIRCULATION. FOR THIS PURPOSE, USE THE REMOVABLE SKIN ATTACHMENT ACCESSORY SUPPLIED OR ELSE A SLIT AT THE END OF THE CANNULA FOR THE SUTURE MATERIAL. THE REMOVABLE SKIN ATTACHMENT ACCESSORY HAS HOLES TO TAKE THE SUTURE MATERIAL. - CAUTION!: CHECK THAT THE CANNULA IS CORRECTLY POSITIONED BY MEANS OF A FLUOROSCOPY UNIT, TRANSESOPHAGEAL ECHOCARDIOGRAPHY, OR OTHER SUITABLE MEASURES. REPEAT THE POSITION CHECK AT REGULAR INTERVALS. - CAUTION!: POSITION THE CANNULA SO THAT IT CANNOT BE KINKED. - CAUTION!: CHECK THE CONNECTION BETWEEN CANNULA AND TUBING SET REGULARLY. - CAUTION!: LOOK OUT FOR SIGNS OF INSUFFICIENT PERFUSION OF THE EXTREMITIES. ALTHOUGH THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE AFFECTED PRODUCT, ALL PRODUCTS SOLD TO THE HOSPITAL ¿ ALONG WITH THEIR RESPECTIVE LOT NUMBERS ¿ WERE RETRIEVED VIA SAP USING THE PROVIDED ARTICLE NUMBER #701047294. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED PRODUCTS WITH LOTS: 3000248772 3000248774 3000294067 3000306002 3000331209 3000336025 3000353387 3000364950 3000367020 3000400267 3000401849 WERE REVIEWED ON 2024-11-14. ACCORDING TO THE DHR RESULTS, THE PRODUCTS BE-PVL 2155 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. BESIDES, A REVIEW OF THE NON-CONFORMITY RECORDS WAS PERFORMED AND THERE COULD NOT BE FOUND ANY NON-CONFORMITIES IN REGARDS TO THE REPORTED FAILURE AND PRODUCT. BASED ON THE INVESTIGATION RESULTS, THE PRODUCT FAILURE RELATED INFLUENCES COULD NOT BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.
PREVIOUS E-MDR WAS SUBMITTED AS MALFUNCTION INSTEAD OF SERIOUS INJURY. THEREFORE, A CORRECTION E-MDR HAS BEEN SUBMITTED WITH THE LABORATORY INVESTIGATION RESULTS. THE SAMPLE WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON 2024-12-16. VISUAL INSPECTION SHOWS A BIG CRACK ON HLS CANNULA CONNECTOR. FURTHER, A SCRATCHES WERE OBSERVED ON CONNECTOR. ADHESIVE RESIDUES WERE FOUND ON THE HLS CANNULA BODY, AND THE PRODUCT MARKS WERE FOUND AS REMOVED. LEAKAGE TEST WAS PERFORMED AND AIR BUBBLES AT THE CRACK OF THE CONNECTOR WAS SEEN. BASED ON THESE, THE COMPLAINT COULD BE CONFIRMED. MEDICAL REVIEW HAS BEEN INITIATED TO EVALUATE THE EVENT FOR FURTHER AND IS ONGOING. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
THE SAMPLE WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON 2024-12-16. VISUAL INSPECTION SHOWS A BIG CRACK ON HLS CANNULA CONNECTOR. FURTHER, A SCRATCHES WERE OBSERVED ON CONNECTOR. ADHESIVE RESIDUES WERE FOUND ON THE HLS CANNULA BODY, AND THE PRODUCT MARKS WERE FOUND AS REMOVED. LEAKAGE TEST WAS PERFORMED AND AIR BUBBLES AT THE CRACK OF THE CONNECTOR WAS SEEN. BASED ON THESE, THE COMPLAINT COULD BE CONFIRMED. MEDICAL REVIEW HAS BEEN INITIATED TO EVALUATE THE EVENT FOR FURTHER AND IS ONGOING. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
THE EVENT OCCURRED IN GERMANY. GETINGE RECEIVED AN AUTHORITY REPORT FROM BFARM ON 2024-10-01 AND THE FOLLOWING WAS REPORTED: AT AROUND 9:54 A.M ON (B)(6) 2024, AIR EMBOLISMS WERE VISIBLE IN THE PATIENT'S LEFT VENTRICLE IN THE TEE. THESE WOULD DISAPPEAR AS SOON AS THE CARDIOHELP CONSOLE WAS TURNED OFF. THE CARDIOHELP AND THE HLS MODULE WAS IMMEDIATELY REPLACED, WHICH MEANT THAT THE AIR EMBOLISMS IN THE LEFT VENTRICLE NO LONGER OCCURRED. A COMPLAINT WAS OPENED IN ONETRACK SYSTEM WITH NUMBER#: (B)(4), MFG REPORT#: 8010762-2024-0000480. DURING THE INVESTIGATION OF THE COMPLAINT#: (B)(4), A NEW INFORMATION WAS RECEIVED ON (B)(6) 2024 AS A SECOND AIR EMBOLISM HAD OCCURRED ON THE SYSTEM. THE SECOND AIR EMBOLISM WAS AT THE VENOUS CANNULA AND CUSTOMER REPLACED THE PRODUCT DURING TREATMENT. AFTER REPLACEMENT, THE FAILURE HAD NOT OCCURRED AGAIN. IT WAS REPORTED THAT THE REPLACED CANNULA SHOWS LONGITUDINAL INCISION. THE REPORTED FAILURE HAD OCCURRED DURING TREATMENT AND HAZARDOUS SITUATION HAD OCCURRED 'AIR EMBOLISM', THEREFORE THE COMPLAINT IS REPORTABLE. COMPLAINT#: (B)(4).
COMPLAINT #(B)(4).
COMPLAINT #(B)(4).
COMPLAINT #(B)(4)
THE COMPLAINT WAS RECEIVED FROM BFARM REPORT. AN AIR EMBOLISM WAS DETECTED ON INTENSIVE CARE PATIENT ON LEFT VENTRICLE. AFTER REPLACEMENT OF CARDIOHELP CONSOLE AND OXYGENATOR, THE AIR EMBOLISM WAS GONE. HOWEVER, A SECOND AIR BUBBLE OCCURRED AGAIN ON LEFT VENTRICLE AND THEREFORE CUSTOMER CHANGED THE HLS CANNULAS. COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1972821 | HLS CANNULA + PIK | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | MAQUET CARDIOPULMONARY GMBH | BE-PVL 2155 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Other |