Infusion Pumps

The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.

Inaccurate Distance and Area measurements with use of Global Stack viewport.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.

Distributed VTM outside of VTM Guidance and without clearance.

Product may be mislabeled.

Product may be mislabeled.

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.

There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.

There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

Kits contain leaking bottles of isopropyl alcohol

A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.

Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.