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

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/02/2022

Event Type  malfunction  

Event Description

Pt was running continuous renal replacement therapy (crrt) with tablo.Charge nurse walked by pt's room and noticed a puddle of blood below the tablo machine.No alarms were on.The top connection on the filter worked itself loose and was spilling blood.Medical icu resident was notified.Tablo was discontinued and a complete blood count was ordered and drawn 1 hour after incident and no significant changes in hemoglobin were noted.

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: 13994640
• MDR Text Key: 288502418
• Report Number: 13994640
• 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
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• 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: 03/09/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White