inforMED
DeathKRI

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

331033-000

Catalog 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.