Events

Safety Alert for CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-09-16
  • Event Date Posted
    2015-09-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150916b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: baxter ce infusor patient control module watch (pcm), 0.5 ml the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning ce infusor patient control module watch (pcm), 0.5 ml [product code 2c1079k; lot number 15a056 and 15b047], manufactured by baxter healthcare. the manufacturer is issuing a recall for the above affected lots of the infusor pcm, 0.5ml due to complaints for partially detached back-plates on the underside of the device. a partial detachment of the pcm back-plate may cause an incomplete shut-off of the pcm watch tubing resulting in continuous flow of medication from the pcm to the patient. the manufacturer has identified the root cause of this issue and corrective actions have been implemented. the affected lots were produced prior to implementation of the corrective actions. continuous flow of pain medication to the patient may result in sedation, respiratory depression, or respiratory failure resulting in the need for medical intervention. these conditions could lead to serious injury or death. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the mhra website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-7-to-11-september-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 september 2015.

Device

CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare