MAUDE Adverse Event Report: SMITHS MEDICAL CADD MEDICATION CASSETTE

Lot Number 16X304

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Respiratory Distress (2045); Anxiety (2328)

Event Date 05/21/2017

Event Type  Injury  

Event Description

Patient admitted to our facility for close monitoring of side effects from chronic pulmonary arterial hypertension.During the night the patient's pca pump that was infusing the patient's pah medication (remodulin), began alarming because of low volume.When the nurse opened the pump, she noticed that the cartridge was full, not empty.This triggered the nurse to immediately change out the cartridge and the pca pump.Patient had been restless and requesting bipap to be removed as he was feeling short of breath.Chronic pah.

• Brand Name: CADD MEDICATION CASSETTE
• Type of Device: CADD MEDICATION CASSETTE
• Manufacturer (Section D): SMITHS MEDICAL; st. paul MN 55112
• MDR Report Key: 6614099
• MDR Text Key: 76850096
• Report Number: MW5070172
• Device Sequence Number: 1
• Product Code: MEA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Lot Number: 16X304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR
• Patient Weight: 128