ICU Mednet(TM) Medication Management Suite 6.1 and 6.21 recall

Why was ICU Mednet(TM) Medication Management Suite 6.1 and 6.21 recalled?

Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. Medication entries are built with the same displayed name and diluent amount AND; 2. The piggyback or interruptible settings differ from one CCA to another AND; 3. The drug library is exported then imported into the MedNet Meds program. The changed drug library may then be finalized and downloaded to infusers for use in clinical settings. The changes are made without any notice provided to either the MedNet Meds user (pharmacist) or to the clinician operating the infuser that the piggyback or interruptible settings have been altered. Issue 2: The MedNet Meds 6.1 program, under certain conditions different from those described above in Issue 1, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. The Master Drug Formulary contains medication entries built with the same displayed name and diluent amounts but one is a Limited rule set and the other is a Full rule set AND; 2. The medication entry built as the Full rule set has a blank medication amount with the medication units in mg AND; 3. Both medication entries have different piggyback options set AND; 4. The drug library is exported then imported into the MedNet Meds program. In this case, the piggyback options will be changed during an import of such drug library.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.