Important Safety Alerts

Medical device manufacturer, Baxter Healthcare Ltd, has issued a medical device safety alert concerning its Prismaflex sets. The affected devices are identified as the following: -

• Prismaflex HF1400 set [Product code.: 107142]
  • All lots with expiration dates between 2020-03-01 to 2021-01-01
• Prismaflex TPE2000 set [Product code.: 107144]
  • All lots with expiration dates between 2021-01-01 to 2022-02-01
• Prismaflex ST100 set [Product code.: 107636]
  • All lots with expiration dates between 2020-03-01 to 2021-02-01
• OXIRIS S [Product code.: 955503]
  • All lots with expiration dates between 2020-03-01 to 2021-03-01
• MARS Treatment Kit type 1116/1 X-MARS [Product code.: 800540]
  • All lots with expiration dates between 2020-11-30 to 2021-10-31

The manufacturer has received customer reports of kinked access lines observed during treatment using Prismaflex sets. If the kink prevents blood flow, it causes the Prismaflex or Prismax Control Unit to alarm. The issue has been isolated to a subset of lots, based on production dates.

Affected users can continue to safely use the affected Prismaflex sets. If a kink is observed before treatment, the Prismaflex set must be replaced as instructed by the Instructions For Use. If a kink is identified during treatment, therapy must be interrupted, extracorporeal blood in the circuit returned to the patient per normal procedure and the set must be replaced to continue therapy.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 3 May 2019