MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/12/2020

Event Type  Death  

Manufacturer Narrative

Literature: title : first case of candida auris isolated from the bloodstream of a mexican patient with serious gastrointestinal complications from severe endometriosis source: infection (2021) 49:523¿525 if information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, a patient with severe gastrointestinal complications, comorbidities, and hospitalizations presented with kidney failure that required hemodialysis therapy.The patient was admitted to the hospital and treated in (b)(6) of 2020 due to abdominal sepsis.Two weeks later the patient¿s fever returned and serial blood cultures from different sites, the central venous catheter and the dialysis catheter (mahurkar), grew yeast (candida parapsilosis and candida auris).The catheter (mahurkar) was changed and c.Auris was isolated from the tip of the catheter.Antibiotics such as caspofungin (70/50 mg/kg) and liposomal amphotericin b (3 mg/kg) were initiated for a total of 18 days, blood cultures were obtained, c.Auris was not isolated and the patient evolved afebrile and stable.One week after discontinuation of antibiotics, the patient presented with sudden abdominal pain and septic shock.Four days later the patient died; however, all cultures from blood and catheter samples taken during that period were negative.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 13017595
• MDR Text Key: 282325518
• Report Number: 3009211636-2021-00369
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Death
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic