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U.S. Department of Health and Human Services

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

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OUTSET MEDICAL, INC. TABLO DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Fluid 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.
 
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Brand NameTABLO
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OUTSET MEDICAL, INC.
3052 orchard drive
san jose CA 95134
MDR Report Key14249884
MDR Text Key290384974
Report Number14249884
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2022
Event Location Hospital
Date Report to Manufacturer04/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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