Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Maquet Cardiopulmonary.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 090 11 18 000
  • Event Initiated Date
    2018-11-27
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13539
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The hcu 40 heater-cooler unit is intended for cooling and warming a patient connected to the extracorporeal perfusion circuit and maintaining the patient temperature at the required level during cardiovascular interventions. the system comprises two separate water circuits with temperature regulation. the first circuit is for connecting the oxygenator heat exchanger and/or the warming/cooling blanket, the second circuit is intended for connecting the cardioplegia heat exchanger. both water circuits of the hcu 40 contain a flow sensor which measures the water flow to ensure an adequate flow from the device to the connected accessories. maquet cardiopulmonary gmbh has received complaints in relation to malfunctions of the hcu 40 flow sensors. a malfunction of the flow sensor causes an error message that prevents further use of the device. the hcu 40 device software supervises the values detected by the flow sensor. a malfunction of the flow sensor generates a signal that is detected by the device firmware as out of range. to prevent further damage or use of a device where the water flow cannot be monitored, the software causes a shut-off of the affected water circuit not allowing desired patient temperature control by this water circuit. typically, the use of the device is prohibited until the malfunction of the flow sensor is corrected by replacement. however the use of the hcu 40 with only one working water circuit is possible.

Device

Heater-Cooler Unit HCU 40
  • Model / Serial
    The FSCA affects all models and all serial numbers of the below-mentioned HCU 40 device below S/N 90441598 : • 70104.4054 HCU 40 High Voltage • 70105.4917 HCU 40 Low Voltage
  • Product Description
    Warming/Cooling Units, Patient, Circulating-Liquid
  • Manufacturer
    Maquet Cardiopulmonary

Manufacturer

Maquet Cardiopulmonary
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Manufacturers representative
    Al-Faisaliah Medical System
  • Source
    SFDA