Type: Stylet for catheter, gastro-urology
Manufacturer: Boston Scientific Corp. Brand: Amplatz Super Stiff UDI-DI: 08714729191193 Model: M0066401090
Event: The patient underwent a planned stone extraction and ureteral stent exchange today. While grasping the right stent, the surgeon removed a piece of broken super-stiff wire in the ureter from the prior stent placement procedure approximately one week ago.
Photo: A blue metallic wire stent measuring approximately 19.6cm long.
Type: Pump, infusion, elastomeric
Manufacturer: Epic International (Thailand) Co. Brand: SmarteZ Lot: C24G038
Event: The patient came in for pump disconnection. Upon assessment, the nurse saw the elastomeric 5-Fluorouracil pump appeared full, all clamps were open, and the sensor was taped to the chest with an adequate amount of tape and good skin contact. The patient states their spouse did think it was fuller than previous times, but they thought it would continue to go down. The physician was made aware, and orders were received. The patient will receive a new 46-hour 5-Fluorouracil pump. The defective device was disconnected and returned to the pharmacy.
Type: Pulse generator, permanent, implantable
Manufacturer: St. Jude Medical (Abbott) Brand: Fortify Assura UDI-DI: 05414734508094 Model: CD2357-40Q Ref: CD2357-40Q
Event: A cardiac device nurse was requested to change the programming on an implantable cardioverter defibrillator (ICD) in a patient prior to a surgical procedure, as is routine. The patient is dependent on his device. A new programmer from the manufacturer was used to reprogram the device. The interrogating nurse was unable to turn off the rate response. The only options for programming were DOOR (dual-chamber rate-modulated asynchronous mode) or VOOR (temperature sensitive rate modulated nondemand pacing mode). The nurse was attempting to put patient in DOO mode (asynchronous pacing). The nurse opened programming options in the magnetic resonance imaging (MRI) window hoping to find DOO mode to disable rate response. Once in the MRI setting screen, the programmer instructed the user to place the wand over the device. No settings were selected at this time. Once the wand was placed over the patient's ICD, the programmer inhibited pacing. This caused the patient to go without a paced beat for about 5-8 seconds. Once the wand was removed from the device, the device resumed pacing. A vendor representative was notified. The representative reports that when a programmer is brand new and you enter the MRI setting for the first time, the wand inhibits pacing. This is a feature that needs to be turned off and avoided with patients who depend on a pacemaker. The patient reported feelings of nausea and severe syncope (fainting), due to lack of a steady heart rhythm.
Type: Monitor, bed patient
Manufacturer: Renu Medical Brand: Stanley Healthcare Bed-check Chair Sensormat UDI-DI: 00816317024024 Model: RM-73030
Event: A Sensormat was placed under the patient and electrical interference was seen on the telemetry monitor. The Sensormat was removed, which resolved the problem.
Type: Heart-Valve, non-allograft tissue Manufacturer: Edwards Lifesciences
Brand: Inspiris Resilia Aortic Valve UDI-DI: 00690103194982 Model: 11500A Ref: 11500A23
Event: The doctor noticed that the valve and leaflets did not look like they normally do and that there was a larger gap in between the leaflets.
Photo: A prosthetic heart valve with a gap between two of the three leaflets.
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