Type: Table, operating-room, electrical
Manufacturer: Skytron
Brand: Skytron 3600B Ultraslide Bed
Model: 3600B
Cat: 3600B
Event: I was called to the operating room (OR) to assist with a bed issue. When I arrived, I found the cardiac anesthesia fellow holding the OR table remote in her hand, with her finger on the "level" button. The patient was sitting upright on the OR table at about a 45-degree angle. Surgery had already started - the chest and sternum were wide open. The doctor was about to cannulate the aorta when the back of the OR table began to raise on its own. No one was touching the remote or the controls on the bed pedestal. The first thought was to unplug it while we figured out what to do. We decided that we would plug the bed back in while someone held the "level" button on the remote. Someone else would simultaneously use the pedestal buttons to move the bed into a safe position. Once this was accomplished, the bed was unplugged again. At the end of the case, the bed was cleaned and moved to the hallway with a "do not use" sign awaiting biomed. A fellow registered nurse came down the hall and asked what was happening with the bed. I showed her the bed at a full 90-degree angle which it did on its own after the patient was transferred to their inpatient bed. She informed me that this same bed had been sent out for the same problem in the past.
Type: Orthopedic stereotaxic instrument
Manufacturer: Stryker/Mako Surgical Corp
Brand: Mako
Lot: 5601843, 5629691
Event: This facility is having recurring issues with screws in this device. We noticed that a screw was missing from the acetabular inserter after use. In another event, the acetabular inserter was missing one screw and had at least two loose screws. The device was used twice on the same day during hip replacements.
Type: Tube, tracheostomy (w/wo connector)
Manufacturer: Smiths Medical
Brand: Portex BLUselect
UDI-DI: 15019517077865
Model: 101/858/080
Lot: 4440315, 4442599
Cat: 101/858/080
Event: A respiratory therapist noticed that a #8 inner tracheostomy cannula did not positively click into place when performing a tracheostomy tube change on a patient in the ICU. The rib around the inner cannula wasn’t clicking into the outer cannula. Instead, it was sliding in and out without difficulty, leading to the inner cannula possibly “popping out.” He tried a second one to find the same issue. Upon investigation, they were the same lot number. They pulled from another lot, and it connected in place as it should. This was confirmed with a second alternate lot number.
Type: Coagulator-cutter, endoscopic, unipolar (and accessories)
Manufacturer: Karl Storz
Brand: SupraLoop
UDI-DI: 04048551393086
Model: 26183MC-S
Lot: 37BD4693
Event: The patient is a healthy adult, who was undergoing surgery to remove her uterus and bilateral tubes with insertion of mesh and sling via laparoscopic port. The physician inserted the SupraLoop. During a medical procedure (cautery) around the uterus, the SupraLoop broke causing injury to the ovary and bowel. General surgery physician was called in to consult and review options with a second physician. The SupraLoop was removed and returned to the packaging, and a new one was used without further issues.
Type: Introducer, catheter
Manufacturer: Baylis Medical Company
Brand: VersaCross Access Solution
UDI-DI: 00685447011736
Model: VXSK0022
Lot: 34735671
Cat: VXSK0022
Event: A sheath was taken out of sterile package and flushed according to manufacturer guidelines by the doctor. The sheath was inside the patient’s right chamber of the heart and crossed into left chamber of the heart where it was noted there was a clot-like image on the intracardiac echocardiography (ICE) catheter - the activated clotting time at this point was >410 seconds. The doctor went into emergency planning to remove the clot and safely removed the sheath. Once the sheath was outside of the patient, the doctor flushed the sheath with saline to find no clots present. The doctor did find a long string of a plastic substance that had come from the sheath. The doctor feels that the clot like image seen on the ICE catheter was the plastic string-like particle. A new sheath was obtained, and the procedure was repeated with no noted complications.
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Type: Oximeter
Manufacturer: Masimo Corp
Brand: Masimoset Rainbow Ras-125c Adult/Pediatric Acoustic Respiration Cloth Sensor
UDI-DI: 10843997007068
Model: 3475
Cat: 3475
Event: Our hospital was expecting a shipment of Masimo Acoustic Sensors two months ago. When that shipment didn't arrive, an inquiry was made to Masimo, who informed our supply chain staff that the production of that unit had moved to a new location and there was a slight delay, but we should expect the shipment shortly. After waiting a month with no parts and our supply almost out, we reached out again with no success. We then looked at replacement options that do not exist and went so far as to look at using expired sensors to use while waiting for Masimo to provide a solution. The sensors are used to monitor patients’ breathing after they come out of general anesthesia and the lack of these sensors prevents us from monitoring this. We are using a different sensor provided from Masimo, which does not stick as well as our usual unit and requires staff to secure the sensor to the patient using a Tegaderm. The supplied amount while we wait is also insufficient, providing us about five days of operation. As of the day of this report, no information has been provided for the continued delay of the sensors.
Type: Automated external defibrillators (non-wearable)
Manufacturer: Physio-Control
Brand: LifePak 15
Model: LifePak 15
Event: The LP15 defibrillators are failing on the user test, which makes them unavailable for use during emergencies and can lead to life-threatening consequences if users take them out of service and believe they don’t function. The problem is that the LP15 defibrillators don't function right after they are powered on. Users must wait five seconds for the user test to pass or they will fail the user test. The user needs to wait for about five seconds before they attempt to initiate the test, otherwise it will fail. This is different from how they behaved in the past, so some of our end-users were getting failures on user tests and were concerned with their overall functionality. According to the manufacturer, this is a known issue and there is no current fix, except asking users to wait five seconds after powering on the device. According to the manufacturer, the newer LP15's that have the latest software version have extra built-in redundancy which requires the user to wait five seconds after turning the unit on before performing the user test. During the power on, the unit is conducting a self-test that must be completed before starting the user test. They also stated that if the user test fails for this reason, the defibrillator is still fully functional, but facilities don’t use defibrillators that fail user tests (especially when not knowing they must wait five seconds before conducting the test) and end up removing them from service. According to the manufacturer: 1. Power unit on. 2. Count to five. 3. Perform User Test.
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