IMACS Users' Guide – Version 1.0 - The International Society for ...

More documents

Recommendations

Info

IMACS Users’ Guide – Version 1.0 12/21/2012 Page 46 of 56 2.10 Adverse Events There are 4 major adverse events which have a form associated with the adverse event: Device Malfunction, Infection, Bleeding and Neurological Dysfunction. AE Device Malfunction The Adverse Event: Device Malfunction Form is to be collected at time of event. Device Malfunction Device malfunction denotes a 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 (low cardiac output state) or death. A failure that was iatrogenic or recipient-induced will be classified as an Iatrogenic/Recipient-Induced Failure. Device failure should be classified according to which components fails as follows: 1) Pump failure (blood contacting components of pump and any motor or other pump actuating mechanism that is housed with the blood contacting components). In the special situation of pump thrombosis, thrombus is documented to be present within the device or its conduits that result in or could potentially induce circulatory failure. 2) Non-pump failure (e.g., external pneumatic drive unit, electric power supply unit, batteries, controller, interconnect cable, compliance chamber) The Adverse Event: Device Malfunction Form is to be collected at time of event. It is very important to collect adverse events for device malfunctions in a timely fashion. FDA has set forth regulations regarding these events. For the purposes of submitting adverse event device malfunction information to the FDA, you must enter any device malfunction event that occurs within 72 hours of the event. Please see CFR guidelines located at this site for further information on these FDA regulations regarding device malfunctions. Enter Device Type: Select appropriate device side (if BiVAD) for this device malfunction event: LVAD RVAD Both Enter Date of event of adverse event: in MMDDYYYY format. Location of patient: Select whether patient was in or out of hospital at time of adverse event. If location was not known, select Unknown.
AE Device Malfunction IMACS Users’ Guide – Version 1.0 12/21/2012 Page 47 of 56 Major pump unit involved: Check all pump units that apply with this adverse event. Blood Pump Suspected Device Thrombosis? Y/N/U If yes, please enter the anticoagulant therapy at time of event (check all that apply): Warfarin Bivalirudin Heparin Fondaparinux Lovenox Dextran Aspirin Ticlopidine Dipyridamole Hirudin Clopidogrel (plavix) Lepirudin Argatroban Ximelagatran None Other, specify, enter other therapy in box provided Drive Unit Failure External Control System Failure For each major pump unit selected a text box will appear at the bottom of the list where you may enter details concerning this adverse event relating to the particular major pump unit selected. Surgical procedure required? If a surgical procedure was required in this device malfunction adverse event, answer Yes and remember to fill out surgical intervention on the Rehospitalization Form. If no surgical procedure was required then answer No. If it is not known if surgical procedure required, select Unknown. Device explanted: Was device explanted at this event? If so, then answer Yes and fill out the Explant form. If the device was not explanted at this event, then answer No. If it is Unknown whether device was explanted at this event, then answer Unknown. Device malfunction adverse event cause patient's death: Did this device malfunction adverse event cause the patient’s death, then answer Yes. If it did not cause the patient’s death, then answer No. If it is not known if this device malfunction adverse event caused this patient’s death, then answer Unknown. Causative or contributing factors to the device malfunction. Select all causes or contributing factors that apply to this device malfunction. o Patient/Device Interaction o Medical Management (interaction between health system and patient) o Primary Device Malfunction o Patient/Disease Related o End of Pump Life o No specific contributing cause identified
Page 1 and 2: ISHLT Mechanically Assisted Circula
Page 3 and 4: IMACS Users’ Guide - Version 1.0
Page 45: IMACS Users’ Guide - Version 1.0

IMACS Users' Guide – Version 1.0 - The International Society for ...

Create successful ePaper yourself

Delete template?

Save as template?