Other Medical Devices

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal.

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.