CELSIOR
Received Jan 17, 2018 · Event occurred Jul 5, 2017
Report 0002123774-2017-00002 · MDR key 7201030
Device
Generic name
Celsior
Manufacturer
Institut Georges Lopez SasModel number
CELSIOR COLD STORAGE SOLUTIONCatalog number
CELSIOR CASE
Lot number
CEL0061
Product problems
- Product Quality Problem
- Incorrect Or Inadequate Test Results
Patient
16 MO
- Death
- Right Ventricular Dysfunction
- Death
- Right Ventricular Dysfunction
Narrative
Description of Event or Problem
DR. (B)(6) FROM THE (B)(6) CALLED (B)(6) MEDICAL AT APPROXIMATELY 10:30 A, FRIDAY, (B)(6) 2017. DR. (B)(6) STATED THAT (B)(6) RECORDED THREE CASES OF RIGHT VENTRICLE DYSFUNCTIONS IN WHICH CELSIOR WAS USED. TWO CASES RECOVERED AFTER TREATMENT AND A THIRD RESULTED IN DEATH. HIS CONCERN WAS BASED ON THE FACT THAT THE PH OF CELSIOR WAS MEASURED AT THE FACILITY AND FOUND IT TO BE APPROXIMATELY 6.87 WHICH WAS BELOW THE IFU STATED PH OF APPROXIMATELY 7.3. THE PH WAS PERFORMED ON A BLOOD GAS PH METER ON AN UNOPENED CELSIOR PACKAGE. DR. (B)(6) STATED THAT (B)(6) (QUALITY CONTROL - (B)(6)) WOULD BE THE POINT PERSON FOR ALL FURTHER COMMUNICATIONS. PRODUCT: CELSIOR, PRODUCT LOT: CEL0061.