In the final days of 2024, the Food and Drug Administration notified the public of safety issues involving medical devices from Olympus, Trokamed, Nuwellis and Baxter. The early alert notices are part of an FDA pilot program launched in November designed to more quickly inform the public of potential high-risk device issues.
Olympus endoscope infection risk tied to 120 injuries
Olympus recommended healthcare providers stop using an endoscope accessory due to an infection risk linked to reports of 120 injuries and one death, according to a Dec. 23 early alert from the FDA.
The injury reports followed procedures in which the MAJ-891 forceps/irrigation plug was used with a cystoscope, an instrument to diagnose urinary tract conditions. The MAJ-891, which enables irrigation and use of endo-therapy accessories, was discontinued from the U.S. market in 2022.
Infection could result from improper reprocessing of the forceps/irrigation plug, Olympus said in a Dec. 18 safety notice to customers. A device may become contaminated if the MAJ-891 is not disconnected from the endoscope and disassembled before reprocessing. Exposure could cause infection, sepsis or death.
The alert also affects ureterscopes, choledochoscopes and hysteroscopes compatible with MAJ-891 devices.
Olympus advised healthcare providers to use alternatives to the MAJ-891. If none is available, providers should closely follow instructions for reprocessing both the endoscopes and accessories.
Trokamed revises endoscope sheath instructions after death
Trokamed told healthcare providers it updated instructions for certain endoscope sheaths after use of the device for the wrong purpose was associated with a patient’s death, the FDA said in a Dec. 20 early alert.
The previous instructions did not clearly state that the mini PCNL sheath should not be used for suction and irrigation, the FDA said. Such use could reduce outflow through the shaft due to blood, tissue and kidney stone fragments, quickly building up pressure within the kidney that may lead to rupture.
The reusable sheath is intended for minimally invasive procedures to examine kidneys and remove kidney stones or other blockages and is designed to bring instruments, telescopes and fluids to the surgical site.
In a Nov. 26 safety notice, Trokamed said customers should not use the mini PCNL sheath as a suction and irrigation device and should temporarily remove the nephroscope from the shaft to flush out kidney stone fragments.
Nuwellis removes certain blood circuits
Nuwellis told customers to immediately discontinue use of some blood circuit devices because the console will terminate therapy if too many alarms are triggered, according to a Dec. 30 early alert. Nuwellis reported three injuries associated with the issue.
The AquaFlexFlow UF 500 Plus blood circuit is used with the Aquadex SmartFlow system to remove excess fluid, primarily salt and water, from patients who have not responded to medical management for fluid overload.
If therapy is terminated, it could cause excess fluid removal from a patient and dehydration, which is especially serious in pediatric patients, the FDA said.
Nuwellis told healthcare providers in a Dec. 11 recall to immediately stop using affected lots of the devices and not to ignore or override any console alarms. When used with the Aquadex SmartFlow and FlexFlow systems, the blood circuit may indicate “Ultrafiltrate weight mismatch” or “Excessive weight mismatch” alarms. If too many weight mismatch alarms occur, the console will terminate therapy with that blood circuit.
A new blood circuit must be prepared to continue therapy.
Baxter recalls some solution sets for inverted clamps
Baxter advised healthcare providers in a Dec. 20 recall letter not to use certain solution sets with Duo-Vent spikes because they were incorrectly assembled with inverted slide clamps, the FDA said. No injuries were reported.
If a device with an inverted slide clamp is loaded on an infusion pump, medication may not be delivered, and the patient’s blood may flow backward into the set and source container. Adverse health consequences could occur if the patient does not receive life-sustaining medication, or if a significant amount of blood is removed, the FDA said in a Dec. 31 early alert.
The solution sets administer fluids from a container to patients through a vascular access device such as an infusion pump. The slide clamp is designed to shut off fluid flow and load the set into the pump.
