NOVOSCI 3/8" X 3/8" STRIGHT CONNECTOR
Received Nov 1, 2022 · Event occurred Aug 19, 2022
Report 15707706 · MDR key 15707706
Device
Generic name
Straight Connector
Manufacturer
Novosci Corp.Model number
331033-000Catalog number
331033-000
Lot number
303932
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
67 YR · Female
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
ON (B)(6) 2022 THE PATIENT UNDERWENT PLACEMENT OF MINIMALLY INVASIVE CENTRIMAG EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WITH LEFT VENTRICULAR APEX DRAINAGE, WITH REMOVAL OF THE AXILLARY IMPELLA CP. ON (B)(6) 2022, THE VENOUS LIMB OF THE PATIENT'S CENTRIMAG ECMO CIRCUIT WAS REMOVED FROM THE RIGHT COMMON FEMORAL VEIN. THE OXYGENATOR WAS THEN REMOVED FROM THE CENTRIMAG CIRCUIT ON (B)(6) 2022 BY A VENTRICULAR ASSIST DEVICE (VAD) FELLOW. PERFUSION ASSESSED THE CONNECTION FOLLOWING REMOVAL OF THE OXYGENATOR AND DETERMINED THAT IT WAS SECURE. ON (B)(6) 2022 THE PATIENT WAS SUCCESSFULLY EXTUBATED. ON (B)(6) 2022, AT APPROXIMATELY 01:52, THE CENTRIMAG ALARM WAS HEARD. AN RN IMMEDIATELY RESPONDED TO FIND THAT THE CENTRIMAG CIRCUIT HAD BECOME DISCONNECTED DISTAL TO THE PUMP. THE CIRCUIT WAS IMMEDIATELY CLAMPED. THE PATIENT ARRESTED, AND CPR WAS INITIATED. A MASSIVE TRANSFUSION PROTOCOL WAS ACTIVATED DUE TO BLOOD LOSS AND A MEMBER OF THE PERFUSION TEAM RECONNECTED THE CENTRIMAG CIRCUIT. THE PATIENT WAS INTUBATED. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED AFTER APPROXIMATELY 30 MINUTES OF CARDIOPULMONARY RESUSCITATION (CPR). THE PATIENT RECEIVED A TOTAL OF 10 UNITS OF PACKED RED BLOOD CELLS, 7 UNITS OF FRESH FROZEN PLASMA AND 2 UNITS OF PLATELETS. SHE WAS FOUND TO HAVE A STEMI AND WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB IN CARDIOGENIC SHOCK. AN LMPELLA CP HEART PUMP WAS PLACED. ANGIOGRAPHY SHOWED TRIPLE-VESSEL CORONARY ARTERY DISEASE, AND DRUG-ELUTING STENTS WERE PLACED IN THE PROXIMAL LAD AND THE MID LAD. THE PATIENT WAS INTUBATED. SHE WAS PLACED ON VA ECMO. SHE WAS NOTED TO HAVE VENTRICULAR TACHYCARDIA FOR WHICH LIDOCAINE WAS STARTED. THE PATIENT WAS THEN TRANSFERRED TO THE CTICU. ADDITIONALLY, SHE WAS TREATED FOR PNEUMONIA, WITH THE CONCERN FOR POSSIBLE ARDS. THE PATIENT DIED ON (B)(6) 2022.