Avoid Using ReadyMED Infusion Pumps with Cubicin

In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to treat certain bacteremias and complicated skin infections.

The company's letter says that a potentially significant impurity has been isolated from reconstituted Cubicin that was stored in ReadyMED pumps. The impurity, 2-mercaptobenzothiazole (MBT), is used in rubber manufacturing. MBT has been reported to leach into medical products from rubber stoppers and syringe components in the past.

The impurity was discovered during lab studies evaluating the stability of reconstituted Cubicin when it was stored in two types of elastomeric infusion pumps: the Ready MED pump and the Eclipse, which is a pump made by I-Flow Corporation. Stability results were acceptable for both types of pumps, but MBT was detected in the samples from the ReadyMED pumps. It was not found in the Eclipse pump samples or control samples. Cubist recommends not using Cubicin with ReadyMED pumps until the impurity issue has been addressed.

The company says it has not identified MBT in reconstituted Cubicin that was stored in the other types of standard infusion systems that were tested. But the company also points out that Cubicin's stability hasn't been evaluated in infusion pumps other than the Eclipse and ReadyMed.

FDA Patient Safety News: June 2008

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=76#4

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Education

Tags:

• device
• drug
• skin
• infection
• bacteremias
• daptomycin
• fda
• impurity
• pump
• readymed
• cubicin