Events

Safety Alert for Plum A+ Single Channel Family of Infusers

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

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
    2012-11-06
  • Event Date Posted
    2012-11-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121106a.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: hospira plum a+ single channel family of infusers the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning plum a+ single channel family of infusers, manufactured by hospira, inc. the affected list numbers were 11005, 11971, 12391 and 20792. hospira issued a field safety notice to inform users that the volume control knob on some plum a+ single channel infusers (located on the back of the infuser) may not function as described in the system operation manual; the direction for” loud” and “quiet” may be reversed. the manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise. in the event the healthcare professional rotates the volume control knob in the direction described in the system operation manual, the audible tone may be the opposite of the desired audio level. while the device will continue to alarm with an audible one of at least 50 dba at the lowest level, inadvertently setting a low tone when a louder level is actually intended may result in an audible alarm that is more difficult to hear. if this happens, it is possible the clinician may not be alerted when an alarm condition occurs and an interruption in therapy may occur. to correct the issue, hospira will update the system operating manual to clarify the instructions for setting the volume. furthermore, hospira will be creating a volume directional label as an additional improvement. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con199544 if you are in possession of the product, please contact your supplier for necessary actions. posted on 6 november 2012.

Device

Plum A+ Single Channel Family of Infusers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira Plum A+ Single Channel Family of Infusers
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DH