SPS-1
Received Jun 30, 2017 · Event occurred Oct 12, 2016
Report 6681021 · MDR key 6681021
Device
Generic name
Set, Perfusion, Kidney, Disposable
Manufacturer
Organ Recovery Systems, Inc.9Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Death
- Fungal Infection
- Multiple Organ Dysfunction Syndrome
- Death
- Fungal Infection
- Multiple Organ Dysfunction Syndrome
Narrative
Description of Event or Problem
THE PATIENT HAD A HEART TRANSPLANT (B)(6) 2016. DAYS LATER THE PATIENT STAYED ON ECMD FOR FIFTEEN DAYS. AT THAT POINT, PATIENT WAS TESTED FOR CANDIDA GLABRATA (TORULOPSIS GLABRATA); E COLI, AND GRAM NEGATIVE RODS IN BLOOD THEN FOR CANDIDA PARAPSILOSIS. THE PATIENT EXPIRED NINE DAYS LATER AND AFTER AUTOPSY, WAS FOUND THAT THE FUNGUS HAD INVADED THE BLOOD VESSELS AND ORGANS OF THE HEART, PERICARDIAL TISSUE, LUNGS AND THYROID WHICH CONTRIBUTED TO MULTIORGAN FAILURE. THE NOTED CAUSE OF DEATH WAS FUNGEM WITH MULTIORGAN FAILURE. MONTHS LATER, WE RECEIVED A NOTICE OF A VOLUNTARY RECALL OF 2 LOTS OF SPS-1-STATIC PRESERVATION SOLUTION. ALTHOUGH THE SOLUTION IS NOT USED FOR HEARTS, IT WAS USED ON THE KIDNEYS RECOVERED FROM THAT DONOR. LOOKING OVER THE PATIENT'S PAST YEAR OF MICROBIOLOGY REPORTS, THERE WAS NO EVIDENCE OR HISTORY OF PRIOR FUNGAL INFECTIONS.