MAUDE Adverse Event Report: CAREFUSION 303, INC. BD ALARIS PCA MODULE; PUMP, INFUSION, PCA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/10/2020

Event Type  malfunction  

Event Description

Morphine 30 mg / 30 ml pca from ims limited (ndc (b)(4)) was being switched-out on a patient and rn noticed there are multiple fractures along the glass vial and drug solution was being leaked into plastic sheath.Patients drug was not running with an in-line filter and glass could have leaked into the drug solution but none was detected.Fda safety report id# (b)(4).

• Brand Name: BD ALARIS PCA MODULE
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): CAREFUSION 303, INC.
• MDR Report Key: 10396403
• MDR Text Key: 202804487
• Report Number: MW5096033
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1