MAUDE Adverse Event Report: BRACCO DIAGNOSTICS INC. CARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510

Model Number 510

Device Problems Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/10/2015

Event Type  Other  

Event Description

In the pet scan procedure room quality control, procedure are performed daily prior to patient infusions.Three qc tasks are completed - the wash, calibration, and level testing to test for the concentration of the undesirable isotopes, sr-82 and sr-85.A bag of saline solution is used to accomplish the qc tests.On the morning of (b)(6) 2015 these testing procedures were done and found to be satisfactory.The saline bag was replaced after the testing was performed as a matter of routine occurrence.The 500 ml ns bag was inadvertently replaced with a 500 ml bag of lactated ringers.Lactated ringer's solution should not be used with the rb-82 generator because it will result in the release of significantly more sr-82/85 in the elution.There were five patients who received pet scans on (b)(6) 2015 with lactated ringers.On the following day, (b)(6) 2015, a nuclear medicine technologist performed the wash, level and calibration test.The wash and level tests were found to be acceptable.The calibration test was completed and a small deviation from the expected reading was noted.The test was repeated with equivalent results.This test indicated lower than expected volume to produce the same activity.Shortly thereafter, it was noticed that the bag hanging on the generator to complete the qc tests did not contain the saline solution and was lactated ringer's solution.Bracco diagnostics, inc.Was called.Patient infusions were cancelled for the day.Patient was called back to hospital on (b)(6) 2015 for radiation survey using a model 14c gm survey meter with no activity above background level detected.Net dose rate was zero.Also see mw5043403, mw5043405 and mw5043407.

• Brand Name: CARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510
• Type of Device: CARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510
• Manufacturer (Section D): BRACCO DIAGNOSTICS INC.
• MDR Report Key: 4884010
• MDR Text Key: 6019649
• Report Number: MW5043406
• Device Sequence Number: 1
• Product Code: JAK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2015
• Device Model Number: 510
• Device Lot Number: 09101-151461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR