Infusion Pumps

Sterility assurance for Ophthalmic knives.

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

Sterility assurance for Ophthalmic knives.

Unreleased software versions were installed on distributed devices without verification or validation.

Sterility assurance for Ophthalmic knives.

Sterility assurance for Ophthalmic knives.

Unreleased software versions were installed on distributed devices without verification or validation.

Sterility assurance for Ophthalmic knives.

There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

An issue has been identified in the production of the RTS873 robotic total stations that may result in the green aiming laser output power being above its laser safety Class 2 classification.

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.