Female patient underwent c-section at (b)(6) due to worsening preeclampsia.Spinal anesthesia was attempted twice, but was not found to be adequate.The patient then required general anesthesia for the delivery of the infant via c-section.Around the time of this event, anesthesia providers at an outside hospital in the area reported anesthesia issues with bupivacaine custom spinal kits used at this user facility.Anesthesia reviewed the lot #s used on this patient that had 2 failed spinals.Facility proceeded to pull all spinal kits with the lot number suspected to be the issue from hospital stock.The kits in question are a custom spinal kit that b.Braun produces for this facility.Bupivacaine is added to this custom kit.B.Braun was notified of this serious issue.There is a temperature warning label on the kit.However, there is significant concern that the temperature requirement for bupivacaine is not being met during transportation.
|