MAUDE Adverse Event Report: PYXIS ES

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

Pamidronate 90mg in 250 ns was ordered for patient with hypercalcemia assoc with cancer.Nurse did not find medication in house.Noted in chart "not available".Ordered via backup process from another facility and administered several hours later.Pyxis es does not send a list of additives to machine so nurse must override med and see if in station.Previous to the es platform, additives were sent to the machine profile as separate line items which could be used for pulling medication.Nurse seem confused about how to pull medication despite education.With es, if not in her machines, she has a list beside the machine that indicates where the medication is loaded.Medication was in-house and did not need to be ordered.Dose delayed as a result, as well as additional costs that were not needed.(b)(6).

• Brand Name: PYXIS ES
• Type of Device: PYXIS ES
• MDR Report Key: 6157982
• MDR Text Key: 62200243
• Report Number: MW5066614
• Device Sequence Number: 1
• Product Code: JQP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PAMIDRONATE DISODIUM