Type: Accessories, Photographic, For Endoscope (Exclude Light Sources)
Manufacturer: Ambu A/S
Brand: Ambu aView 2 Advance
Model #: aView 2 Advance
Event: A monitor in the Emergency Department was being installed on a new roll stand cart purchased from the manufacturer for that specific purpose. The user was screwing the monitor onto the stand and found it was a bit loose. As he was unscrewing it, the monitor started to spark and caught on fire. The flame was put out by using a fire extinguisher. The fire department came and took the device outside. The user never met any resistance while screwing or unscrewing the monitor from the roll stand. The screw length was 30mm. No patients were involved or harmed, and no staff were injured in this event.
Type: Device, Hemostasis, Vascular
Manufacturer: Abbott Vascular
Brand: Perclose ProGlide
Model #: 12673-03
Lot #: 2101341
Cat #: 12673-03
Event: An ultrasound was used to identify the right common femoral artery, and this was accessed percutaneously with a micro puncture set. An 8Fr dilator was passed, and two Perclose devices were placed. An 8Fr sheath was then placed over the wire into the right common femoral artery. Ultrasound was then used to access the left common femoral using a micro puncture wire and sheath. We then placed a wire and exchanged the micro puncture sheath and dilated the arteriotomy with an 8Fr dilator. The Perclose device was then placed; however, the Perclose could not be advanced or removed. We therefore cut down on the common femoral artery and dissected the common femoral proximal to the access point and dissected the profunda and superficial femoral artery. All three were encircled with silastic vessel loops. Then, we fully anticoagulated the patient with IV heparin and gave additional boluses throughout the case based on activated clotting time (ACT) to maintain ACT. We cinched the vessel loops to clamp the artery proximally and distally. An 11 blade was then used to create an arteriotomy, and we extended this with a scissor. The Perclose device fractured at the arteriotomy, the foot plate became deployed in the artery, and we were unable to recapture the footplate. By extending the arteriotomy we were able to remove the device in its entirety. We then debrided the artery and performed a common femoral endarterectomy. We used bovine pericardium to perform a patch angioplasty of the artery.
Type: Tube, Tracheal (W/wo Connector)
Manufacturer: Bryan Medical, Inc.
Brand: Tenax Laser Resistant Endotracheal Tube
Model #: TG0060
Lot #: 1206320C
Cat #: TG0060-S
Event: We tested multiple anesthesia laser tubes prior to our case and saw they were not working properly. The distal balloon was not inflating on one, and the proximal balloon was not inflating on the other. Additionally, the cuff was not inflating properly. Upon closer inspection, we noticed the lot number on the box for the Tenax laser resistant endotracheal tube kit is not the same as the lot number on the actual package. We did find one tube that worked with the same lot number of those that failed.
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Type: Catheter, hemodialysis, implanted
Manufacturer: Bard Peripheral Vascular, Inc.
Brand: GlidePath
Model #: 5373080 | Cat #: 5373080; Model #: 5373100 | Cat #: 5373100;
Model #: 5373120 | Cat #: 5373120; Model #: 5373150 | Cat #: 5373150;
Model #: 5373190 | Cat #: 5373190; Model #: 5303100 | Cat #: 5303100;
Model #: 5303120 | Cat #: 5303120; Model #: 5304150 | Cat #: 5304150;
Model #: 5303190 | Cat #: 5303190; Model #: 5303230 | Cat #: 5303230;
Model #: 5343150 | Cat #: 5343150; Model #: 5343190 | Cat #: 5343190;
Model #: 5343230 | Cat #: 5343230; Model #: 5343270 | Cat #: 5343270;
Model #: 5343310 | Cat #: 5343310; Model #: 5343350 | Cat #: 5343350;
Model #: 5347150 | Cat #: 5347150; Model #: 5347190 | Cat #: 5347190;
Model #: 5347230 | Cat #: 5347230; Model #: 5347270 | Cat #: 5347270;
Model #: 5347310 | Cat #: 5347310; Model #: 5347350 | Cat #: 5347350
Event: We have been experiencing widespread backorders on dialysis catheters with no reliable estimated time of arrival for recovery. The hospital inventory has dropped into the single digits a few times. Occasionally, product has been shared amongst other hospitals within the Western U.S., but other locations also are experiencing this shortage. The issue mainly revolves around the cuffed long-term catheters, specifically most hemodialysis catheters within the 7.5 FR - 13 FR range. Alternate product from a different medical device manufacturer has been explored; however, availability is also limited on these. A BD representative has been able to assist with locating and re-routing some product, and we are awaiting feedback from BD on alternative devices to use in the interim. Placing orders has proven difficult due to nationwide backorders and supply chain issues experienced by three separate medical device manufacturers. There also are concerns about catheters being discarded because they are past their expiration date.
Type: Bronchoscope (flexible or rigid)
Device 1:
Manufacturer: Intuitive Surgical, Inc.
Brand: Ion
Model #: 380748
Other #: 511163-06 and 504013-01
Device 2:
Model #: IF1000
Cat #: IF1000
Event: The patient had a Non-ST-Elevation Myocardial Infarction (NSTEMI) during flexible bronchoscopy and CT-guided biopsies. During the procedure, the patient developed a bradycardic arrhythmia and low blood pressure. The patient was given multiple stabilizing medications and a 12 lead EKG. After looking at the EKG, a code STEMI was called and the cath lab and cardiology got involved. After the catheterization, the team noted a complete obstruction of the right coronary artery. Testing showed the patient may have suffered an air embolus. The patient had multiple ventricular fibrillation arrests while in the catheterization lab. A heart pump was placed, and the patient was sent to the intensive care unit. The patient died the following day. The team is unsure if the Ion robot played a part in the event.
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