MAUDE Adverse Event Report: RBM SERVICES L.L.C. CARDIOGEN-82 INFUSION SYSTEM; PUMP, INFUSION

Model Number MODEL 510

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Overdose (1988)

Event Date 10/29/2020

Event Type  malfunction  

Event Description

When i did my "rip and refill" on the generator, i inadvertently hit the inject button instead of the refill.I heard the generator start to deliver and realized what i had done.I immediately stopped that injection.The patient received an additional 2.2 mci dose of rubidium 4 min post her initial 30 mci injection.The radiologist said images were not affected and we are still within our 10% window on dosing, so there was no misadministration.The pa was informed of the total dose for documentation.

• Brand Name: CARDIOGEN-82 INFUSION SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): RBM SERVICES L.L.C.; 101 valley ct ste b; oak ridge TN 37830
• MDR Report Key: 11071875
• MDR Text Key: 223594627
• Report Number: 11071875
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MODEL 510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1