MAUDE Adverse Event Report: CME AMERICA BODY GUARD 323 INFUSING PUMPS

Device Problem Application Program Problem: Medication Error (3198)

Patient Problem Overdose (1988)

Event Date 10/20/2016

Event Type  Injury  

Event Description

A chemotherapy agent that should have infused at 13.3 ml/hr over 48 hours was infused at 641 ml/hr, less than 2 hours.

• Brand Name: BODY GUARD 323 INFUSING PUMPS
• Type of Device: BODY GUARD 323 INFUSING PUMPS
• Manufacturer (Section D): CME AMERICA; golden CO
• MDR Report Key: 6155938
• MDR Text Key: 61868940
• Report Number: 6155938
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/21/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2016
• Distributor Facility Aware Date: 10/21/2016
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2016
• 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): Hospitalization; Life Threatening; Required Intervention