MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO(R) HEMODIALYSIS SYSTEM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

Patient had positive blood culture while on dialysis treatment.Three dialysis patients from medical icu were reported to have central line-associated bloodstream infections.A deeper look into this identified an association between the patients and the tablo device ((b)(4)).The device was used for treatment for a 2-week period.Patients all had positive blood cultures after they received dialysis from the device.Recommend: review disinfectant logs and lab reports for machine.Look to see if there is a trend with positive blood cultures and dialysis.Investigate machine for mechanical failures that would lead to contamination.

Event Description

Patient had positive blood culture while on dialysis treatment.Three dialysis patients from medical icu were reported to have central line-associated bloodstream infections.A deeper look into this identified an association between the patients and the tablo device.The device was used for treatment for a 2-week period.Patients all had positive blood cultures after they received dialysis from the device.Recommend: review disinfectant logs and lab reports for machine.Look to see if there is a trend with positive blood cultures and dialysis.Investigate machine for mechanical failures that would lead to contamination.

Event Description

No equipment issues or human factors interacting with equipment identified.

• Brand Name: TABLO(R) HEMODIALYSIS SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• MDR Report Key: 13839287
• MDR Text Key: 287548628
• Report Number: 13839287
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Race: Black Or African American