Imaging Visual Inspection Manufacturer’s Report Device Malfunction Event If a thrombus (suspected or confirmed) is associated with this device malfunction event please remember to fill out the thrombus specific section of this form. Did the patient experience a device malfunction (failure of one or more of the components of the MCSD system which either directly causes or could potentially induce a state of inadequate circulatory support or death)? Yes, No, or Unknown If please select all of the components that apply: yes, Pump Pump Body (including bearings and rotor) Driveline Inflow Cannula Outflow (including bend relief) Controller / Driver Primary System Failure (running in backup mode) Complete System Failure (primary and backup failure) Power Cable (attached to controller) Power Connectors (attached to controller) Peripherals External Battery Cell Battery (in controller) Module Patient Cable System Monitor / Display Battery Charger Battery Clip Outcomes of Device Adverse Event: Malfunction / Failure and/or Pump Thrombus Patient Outcome: Select all that apply: Death (complete the death form) Serious Injury (see FDA/CDRH definition below) Urgent Transplantation (complete the transplant/explant form) Explant Without Replacement (complete the explant form) Exchange (complete the explant form) Breach of Integrity of Line that Required Repair Surgical Procedure None of the Above Causative or Contributing Factors to the Device Adverse Event: Select all that apply: Patient Accident
Imaging Visual Inspection Manufacturer’s Report Device Malfunction Event If a thrombus (suspected or confirmed) is associated with this device malfunction event please remember to fill out the thrombus specific section of this form. Did the patient experience a device malfunction (failure of one or more of the components of the MCSD system which either directly causes or could potentially induce a state of inadequate circulatory support or death)? Yes, No, or Unknown If yes, please select all of the components that apply: Pump Pump Body (including bearings and rotor) Driveline Inflow Cannula Outflow (including bend relief) Controller / Driver Primary System Failure (running in backup mode) Complete System Failure (primary and backup failure) Power Cable (attached to controller) Power Connectors (attached to controller) Peripherals External Battery Cell Battery (in controller) Module Patient Cable System Monitor / Display Battery Charger Battery Clip Outcomes of Device Adverse Event: Malfunction / Failure and/or Pump Thrombus Patient Outcome: Select all that apply: Death (complete the death form) Serious Injury (see FDA/CDRH definition below) Urgent Transplantation (complete the transplant/explant form) Explant Without Replacement (complete the explant form) Exchange (complete the explant form) Breach of Integrity of Line that Required Repair Surgical Procedure None of the Above Causative or Contributing Factors to the Device Adverse Event: Select all that apply: Patient Accident
PediMACS_Users_Guide_v4_0_2014_09_30.docx