HLS CANNULA + PIK
Report
- Report Number
- 3008355164-2024-00016
- Event Type
- Injury
- Date Received
- May 2, 2024
- Date of Event
- April 10, 2024
- Report Date
- August 13, 2024
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DWF
- PMA / PMN Number
- K102532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
THE COMPLAINT IS RECEIVED FROM AUTHORITY REPORT BFARM NO. (B)(4). IT WAS REPORTED THAT A PATIENT WAS BEING TREATED WITH A HLS CANNULAE INCLUDING WITH SUPPLY AND DISCHARGE TUBE SYSTEM WITH OXYGENATOR. THE TUBE SYSTEM HAD TO BE CHANGED ON (B)(6) 2024. WHILE CUSTOMER DETACHED THE TUBE FROM CONNECTOR FOR CHANGE, THE CONNECTOR WAS BROKE OFF UNDER A SLIGHT FORCE. DAMAGED TO THE PATIENT WAS AVOIDED BY CUSTOMER. IT WAS REPORTED THAT THE INFECTION STATUS IS UNKNOWN BY THE HOSPITAL. DUE TO THIS, SAMPLE INVESTIGATION COULD NOT BE PERFORMED. HOWEVER, PHOTOGRAPHICAL EVIDENCE WAS PROVIDED, FAILURE COULD BE CONFIRMED. GETINGE MEDICAL AFFAIRS PERFORMED A MEDICAL REVIEW ON 2024-07-16 AS FOLLOWS: THE COMPLAINT REPORT EXPLAINS THAT THE ECMO SYSTEM OF A VENO-VENOUS ECMO CIRCUIT HAD TO BE CHANGED ON (B)(6) 2024. IT IS NOT DESCRIBED IN THE COMPLAINT NARRATIVE WHY THE EXCHANGE WAS NECESSARY. DURING THE EXCHANGE OF THE SUPPORT CIRCUIT, THE DRAINAGE AND RETURN CANNULAS WERE LEFT IN THE PATIENT WHILE THE TUBES WERE DETACHED FROM THE CONNECTORS. UPON DISCONNECTION OF THE TUBING FROM THE DRAINAGE CANNULA, A PART OF THE CONNECTOR BROKE OFF. THE FORCE APPLIED TO THE CONNECTOR DURING THE CANNULA EXCHANGE WAS DESCRIBED AS ¿SLIGHT¿. THE DETACHMENT OF A PORTION OF THE CONNECTORS REQUIRED AN EMERGENT REPLACEMENT OF THE CANNULA. HARM TO THE PATIENT WAS AVOIDED. CONTRIBUTORY CAUSES THAT MIGHT HAVE DAMAGED THE CANNULA CONNECTOR OVER TIME SHOULD BE CONSIDERED. IT IS POSSIBLE THAT TRANSPORT OF THE PATIENT MAY HAVE CONTRIBUTED TO A CONNECTOR FRACTURE THAT DEGRADED OVER TIME. THAT SAID, IT IS UNCLEAR (FROM A READING OF THE COMPLAINT NARRATIVE) IF TRANSPORTATION OF THE PATIENT OCCURRED DURING THE PERIOD OF EXTRACORPOREAL SUPPORT. FURTHER, IT IS POSSIBLE THAT MOVEMENT OF THE PATIENT (REPOSITIONING, PRONING, AMBULATION, ETC.) MAY HAVE CAUSED INITIAL DAMAGE TO THE CONNECTOR. AN EXTENDED PERIOD OF LINE/CANNULA TENSION MAY HAVE SERVED TO PROPAGATE A FISSURE THAT WAS ALREADY PRESENT. BFARM DESCRIBED DIFFERENT RISKS FOR THE PATIENT THAT MAY HAVE OCCURRED SECONDARY TO CONNECTOR BREAKAGE. THE RISKS/HARMS CITED BY BFARM OF AN UNNOTICED BREAKAGE IN THE CANNULA CONNECTOR DURING MOBILIZATION INCLUDE THE FOLLOWING: ¿ HEMORRHAGIC SHOCK (IT IS ASSUMED THIS IS SECONDARY TO EXSANGUINATION) ¿ AIR EMBOLISM ¿ HYPOXIA ¿ RESPIRATORY EXHAUSTION ¿ INFECTION ¿ THROMBOSIS ¿ DEATH. THE RISKS CITED BY BFARM ARE, INDEED, RISKS/HARMS POSSIBLE IN THIS CASE, ALTHOUGH, SOME LESS THAN OTHERS. HOWEVER, ALL OF THE HARMS PRESENTED PRESENT AS POSSIBILITIES EXTRACORPOREAL CIRCULATION IN GENERAL. WITHOUT DIRECT INSPECTION OF THE CANNULA ITSELF, IT IS CHALLENGING TO ASSIGN A ROOT CAUSE OF THE EVENT TO LOSS A OF STRUCTURAL INTEGRITY OF THE CANNULA CONNECTOR, TO UNINTENDED (SIGNIFICANT) MECHANICAL TENSION PLACED ON THE CANNULA CONNECTOR AND LINES DURING PATIENT SUPPORT, OR TO BOTH. LAST, IT IS UNKNOWN HOW LONG THE PATIENT WAS ON SUPPORT AND WHETHER THE PERIOD OF SUPPORT INFLUENCED THE REPORTED EVENT. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED BE-PVS 2538 WITH LOT# 3000367061 WAS REVIEWED ON 2024-06-14. ACCORDING TO THE DHR RESULT, THE PRODUCT BE-PVS 2538 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS, PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE INCOMING INSPECTION REPORT (BATCH # 3000326255) OF THE AFFECTED COMPONENT "700000284 / 00284#KONNEKTOR 3/8 X 3/8" WAS REVIEWED ON 2024-06-14. THE CONNECTOR WERE CHECKED FOR DAMAGES, SCRATCHES, MARKS, RILLS, SINKS, STREAKS, AND CORDS VISUALLY. VISUAL TESTS WERE PASSED AS PER SPECIFICATIONS. DUE TO THIS, MATERIAL RELATED INFLUENCES ARE UNLIKELY. FURTHER, THE INCOMING INSPECTION REPORT (BATCHES #3000260135 AND 3000260137) OF THE AFFECTED COMPONENT ¿701046352 / FEM BODY25_VS-01#PERI.CATH.BODY 25FR, VS" WAS REVIEWED ON 2024-06-14. THE CATHETER BODY WERE CHECKED FOR OPEN BUBBLES, PARTICLES, RIDGES, SHARP EDGES, CRACKS, STREAKS, DIRT, BLACK SPOT AND AIR BUBBLES VISUALLY. VISUAL TESTS WERE PASSED AS PER SPECIFICATIONS. DUE TO THIS, MATERIAL RELATED INFLUENCES ARE UNLIKELY. 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.
A FOLLOW-UP MED-WATCH WILL BE SUBMITTED WHEN FUTURE INFORMATION BECOMES AVAILABLE.
COMPLAINT #(B)(4).
A NOTIFICATION WAS RECEIVED BY GERMANY AUTHORITY B FARM NO. 2205/24. IT WAS REPORTED THAT THE PATIENT IS BEING TREATED WITH A VENOVENOUS ECMO AND THE SYSTEM / OXYGENATOR WITH SUPPLY AND DISCHARGE TUBE SYSTEM HAD TO BE CHANGED ON APRIL 10, 2024. AS USUAL, THE DELIVERY AND RETURN CANNULAS WERE LEFT IN THE PATIENT AND THE TUBES WERE DETACHED FROM THE CONNECTOR PIECE (AN INTEGRAL PART OF THE ECMO CANNULAS). THE CONNECTOR BROKE OFF UNDER SLIGHT FORCE WHILE THE RUBBER TUBE WAS BEING DETACHED FROM THE HARD PLASTIC CONNECTOR ON THE DELIVERY CANNULA, SO THAT A NEW INSTALLATION WAS NECESSARY AS AN EMERGENCY - (USING SELDINGER TECHNOLOGY) OR RE-SELDING OVER OLD, DAMAGED CANNULAS. DAMAGE TO THE PATIENT WAS AVOIDED. COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 811767 | HLS CANNULA + PIK | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | MAQUET CARDIOPULMONARY GMBH | BE-PVS 2538 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |