Type: Kit, Earmold, Impression
Manufacturer: Westone Laboratories, Inc.
Brand: Westone Foam Ear Dam
Model: 20314
Cat: 20314
Event: This product contributed to patient harm. There have been 13 events with multiple reports involving: patient ear bleeding, pain, discomfort, product unable to be removed from patient’s ear resulting in an additional surgery, and tympanic membrane perforations. The purpose of the foam oto-block is to keep silicone material from moving further in the canal. If it fails, silicone can be pressed up against the tympanic membrane. Worst case scenario is if there is a perforation or a pressure equalization tube because the silicone can go into the middle ear space and require surgery to correct.
 Left to right: Example showing correct placement/foam block and foam block shows no deformity or shrinkage; foam block flipped sideways in the ear canal and shrunk 2.5-3.5 mm (an unaffected device is next to the deformed foam block for comparison); silicone penetrated (bracketed in red) the foam block and came to rest in the bony portion of the ear but not yet touching the tympanic membrane.
Type: Catheter, Straight
Manufacturer: Medline Industries, Inc.
Brand: Catheter, Urethral, Vinyl, Pedi, 10", 8Fr
Model: DYND10713 | Cat: DYND10713 | DI: 10080196846818
Brand: Catheter, Urethral, Vinyl, Male, 16", 10 Fr
Model: DYND10721 | Cat: DYND10721 | DI: 10080196846801
Brand: Catheter, Urethral, Vinyl, Male, 16", 12 Fr
Model: DYND10722 | Cat: DYND10722 | DI: 10080196846818
Event: Medline ureteral catheters are being used as a replacement for another brand of catheters. There have been multiple complaints from surgeons that the Medline catheters are too flexible. They also are clear, which makes dissection challenging when using them as a guide. With the Medline catheters, there have been reports of excoriated adenoids causing more bleeding during adenoidectomy cases.
Type: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer: NxStage Medical Inc.
Brand: Nxstage Cartridge Express
Model: CAR-500
Lot: 30878041
Cat: CAR-500
DI: M535CAR5000
Event: After hooking the patient up to the continuous veno-venous hemofiltration filter, it started pulling from the venous or blue tubes when it should have been pulling from the arterial or red tubing. Also, while priming the tubing, it added fluid to the saline bag, which increases the risk of bursting.
Type: Injector and Syringe, Angiographic
Manufacturer: Bracco Engineering SA
Brand: FastLoad CTA Dual Syringe Pack with Spikes
Model: 017355
Lot: 242411
Cat: 017355
DI: 17630039300873
Event: The patient was being injected through a power port and the contrast syringe broke and popped off the power injector. Plastic pieces dispersed, but a curtain barrier was used and the patient was not harmed. Injector syringes were replaced and a test completed successfully.
The photo shows two contrast syringes. The bottom syringe is intact whereas the one on top is missing part of the clear barrel and white tabs from the phalange have come off.
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Type: Hysteroscope (And Accessories)
Manufacturer: Hologic, Inc.
Brand: Fluent Fluid Management System
Model: FLT-112S, FLT-112
Lot: 23E02RN, 23G18RD
Cat: FLT-112S
DI: 15420045507401
Event: Multiple clinical sites reported multiple issues with the disposable cartridges/kits used with the Hologic Fluent Management Systems. This device was used with machine/device model: FLT-100 (new), or RM-FLT-100 (remanufactured).
1) Fluent cartridges have been leaking for 1.5 years despite the user sites working with the local representative. Initially the representative informed the site they had and would exchange cartridges. No notice or recall was communicated. It is now across all sites and all lot numbers, but sites have come to expect this from the product, so they have not been reporting.
2) Difficulty loading cartridges due to failure of machine sensor to detect the cartridge heads requiring work-arounds. The machine has a sensor to detect a white strip inside the cartridge heads. When the sensor detects the presence of the cartridge, it engages a magnet to load and start the cartridge. The white strip on the cartridges is coming very faded in new cartridges, and the clinical staff have developed a work-around to engage the sensor by putting a piece of white paper or sticker inside the cartridge head. This poses its own risks, but otherwise the machine will not function or load the cartridge. We found similar reports for this machine and cartridges in MAUDE. The most recent events include: The cartridge would not load; multiple attempts to troubleshoot with the manufacturer. The device was leaking. The device was leaking (2nd occurrence). The cartridge would not load.
Over the last 1.5 years, we have been working with the manufacturer; however, the device problem is still present. Samples were frequently provided to the manufacturer’s representative. Clinical Engineering has ruled out the machines as a root cause for the leaks. Hologic still exchanged our machines and gave us refurbished/remanufactured machines and the same issue is occurring. Potential for patient harm is a concern. No known significant safety events have been reported internally due to this issue. This is included but not limited to fluid overload, too much fluid being left inside the patient with the management system unable to perform its primary function of intake and output properly. Supply Chain messaged to perioperative sites to report all issues with these machines so we can document the failures and report them, also use them to talk through with the Manufacturer. We are escalating this to Hologic Quality.
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