Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Hospira Inc. A Pfizer Company
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Class I - Dangerous
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Class I - Dangerous
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.
Class I - Dangerous
Lack of Sterility Assurance: customer report of leaking bag
Class I - Dangerous
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Class I - Dangerous
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Class I - Dangerous
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.