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

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

S: malfunction of tablo - breakage/bleeding within cartridge during blood return.B: patient on tablo with multiple repetitive alarms, machine would not continue.Attempted to have machine return blood, but machine would not, more alarms.Just prior to 7 minutes we attempted to hand cranked blood back to patient, blood leakage noted in cartridge/machine during hand cranking.A: it was brought to my attention after the fact that we did not turn the locks prior to hand cranking blood back to patient.Time was running out for blood return, so it was done quickly without consulting the manual.Unknown if this may have contributed to breakage of the cartridge.R: re-educate on process of blood return, and/or assess tablo machine/cartridge for functionality.Time was short, stress levels high, the machine clearly not functioning.I was the charge rn admitting my second covid patient and did not think to consult the manual when called into this room to assist with a malfunctioning tablo machine.No tablo reps or assistants were in house, the clock was ticking on the 7 minute to return blood to our patient who was maxed on epi, levo, vaso.

Event Description

No equipment issues or human factors interacting with equipment identified.

• Brand Name: TABLO
• 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: 14249884
• MDR Text Key: 290384974
• Report Number: 14249884
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 04/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female
• Patient Weight: 120 KG