MAUDE Adverse Event Report: SORIN GROUP USA INC. STOCKERT 3T HEATER-COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Granuloma (1876); Hepatitis (1897)

Event Date 06/18/2014

Event Type  Injury  

Event Description

Patient with history prostate cancer, thoracic aorta repair with aortic valve replacement 2 years ago, with insidious onset of illness with night sweats, weight loss, renal injury, mild transaminitis, splenomegaly, bilateral choroiditis, leukopenia, and anemia.Recently admitted about 2 months ago for about 3 weeks and liver biopsy during admission revealed acute hepatitis with granulomas.Two acid-fast bacillus (afb) blood cultures have turned positive recently.Patient was admitted with worsening renal function about a month ago.Patient underwent renal biopsy.Report of the renal biopsy appears to be consistent with acute interstitial nephritis (ain) (diffuse interstitial infiltrates, some giant cells - full report to follow).Acute kidney injury (aki) based on biopsy nephrology is concerned the patient is having ain and of his mediations rifampin seems to be the more likely culprit.Disseminated nontuberculous mycobacterial infection, suspected to be m.Chimaera, started on therapy 3 days after being admitted.

• Brand Name: STOCKERT 3T HEATER-COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA INC.; 14401 west 65th way; arvada, co 80004 CO 80004
• MDR Report Key: 6165950
• MDR Text Key: 62109835
• Report Number: 6165950
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 85