CARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-24 for CARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510 manufactured by Bracco Diagnostics Inc.

Event Text Entries

[21770615] 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 - mw5043407.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5043404
MDR Report Key4884004
Date Received2015-06-24
Date of Report2015-06-19
Date of Event2015-06-10
Date Added to Maude2015-07-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510
Generic NameCARDIOGEN-82 RUBIDIUM RB82 GENERATOR-#510
Product CodeOUO
Date Received2015-06-24
Returned To Mfg2015-06-18
Model Number510
Lot Number09101-151461
Device Expiration Date2015-07-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No0
Device Event Key0
ManufacturerBRACCO DIAGNOSTICS INC


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-24

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