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Medical device incident investigations, March 2006
Misidentification of CADD Legacy Plus pump leading to over-infusion
The TGA received a report that a patient received a 24times overdose of a cytotoxic drug when a CADD Legacy Plus pump (programmed in mL/hr) was substituted for a CADD Legacy 1 pump (programmed in mL/day). Smiths Medical has issued a Safety Alert in Australia that warns of the consequences of substituting one model with the other without making the appropriate changes in dose rates required by the two models.
Part of the corrective actions requested by the TGA in relation to the above DIR was for the manufacturer to amend the user manuals to assist with correct product model identification.
Smiths Medical has now released the amended versions of the Operator Manuals and the Patient Information Manuals for the CADD Legacy Plus and Legacy 1 infusion pumps.
- have revised front covers, coloured to match the labels on the device model
- display the model type in a highlighted circle
- display the delivery rate in a highlighted box.
The inside front cover now:
- has text emphasising which model the manual refers to
- brings to the attention of the user the existence of other CADD pump models
- advises the user to check the model they have before programming
- again emphasises the delivery rate of the device in question.
Smiths Medical is now issuing these new manuals with all new pumps distributed and are implementing the replacement of all existing manuals in the field in conjunction with their Product Specialists providing refresher training for all customers/users of these pumps.
On 13 March 2006 the TGA received a report about an incident in which a patient received an overinfusion of a cytotoxic drug after a CADD-1 pump was mistaken for a CADD Legacy Plus pump. CADD-1 pumps have not been supplied for several years but may still be in widespread use. There are more visual differences between the CADD-1 and the CADD Legacy Plus (for example, smaller screen, differently-shaped keys, ribbing on the case, shape of case) than between the CADD Legacy 1 and the CADD Legacy Plus (see previous report, DIR 14928).
The TGA is currently investigating this latest report, but in the meantime users are advised to check the units of dose rate very carefully prior to using any of these pumps.
Device incident reports 01/10/2005 to 31/12/2005
Number received: 174
|Not Applicable - ADR2||1|
|Not Device Related||28|
|Hospital Supply Service||12|
|No Further Action||31|
|Problem Not Confirmed||8|
- The problem causes are not mutually exclusive. For example, a material deficiency may have led to a mechanical malfunction or a biocompatibility problem.
- ADR stands for Australian Device Regulatory [Action]. These devices are not on the Australian Register of Therapeutic Goods (ARTG) and companies are notified and/or warned that they must place the device on the ARTG prior to further supply.
- Every report received by IRIS receives a risk analysis by the Scheme Coordinator and is discussed by a panel of technical and clinical professionals. In the case of reports that are "Not Investigated" the panel has made a decision that further investigation of the particular event is not necessary at that time. However, these reports are logged into the database for future reference and the trend of reports is monitored. In making their decision, the panel considers whether any similar reports have been received previously.