MAUDE Adverse Event Report: CHEMOLOCK; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

Etoposide was hung as a secondary infusion to go over 1 hour.Dose and rate verified by 2 rns.Secondary clamp verified open.Infusion started, and it was noted approximately 40 min into the infusion that the bag of chemo was finishing.It was identified that it was running by gravity, not the rate set on the pump.

• Brand Name: CHEMOLOCK
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• MDR Report Key: 11093598
• MDR Text Key: 224255282
• Report Number: 11093598
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1