Medical device manufacturer, Baxter, has issued a medical device alert concerning its COLLEAGUE SINGLE CHANNEL CXE [Product code: 2M91617, PNM91617, BRM91617, 2M91637A, All serial numbers] and COLLEAGUE TRIPLE CHANNEL CXE [Product code: PNM91637. 2M91637, BRM91637, 2M81537K, BRM81537, CNM81537, DNM81537, GNM81537, HNM81537, WNM81537, All serial numbers].
The manufacturer has identified that the Colleague P1.7 Large Volumetric Pump (LVP) Operator's Manual and Global Service Manual require updates to include flow rate accuracy claims for non-DiEthylHexylPhthalate (DEHP) administration sets. Using non-DHEP sets may result in under infusion at flow rates above 1,000 mL/hr. This may harm the patient depending on several factors such as the medication being infused, the volume and rate of the infusion, patient status, and comorbidities. To date, there have been no reports of patient injury associated with this issue.
The manufacturer will be updating the Colleague P1.7 Operator's Manual and Global Service Manual to include an addendum, which defines the requirements for flow rate accuracy specific to non-DEHP administration sets. Customers will be informed once the updated manuals are made available, Meanwhile, operators may continue to safely use the Colleague P1.7 LVP with DEHP administration sets. When using non-DEHP administration sets, users should be aware of the new flow rate accuracy claims and do not use non-DEHP sets for infusion rates of over 1,000 mL/hr.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 9 March 2021