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U.S. Department of Health and Human Services

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

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OUTSET MEDICAL, INC. TABLO(R) HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Obstruction of Flow (2423); Pressure Problem (3012); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2022
Event Type  malfunction  
Event Description
Pt was on tablo with 5 hours remaining when nurse got high arterial pressure alarms. Nurse noticed that the arterial line attached to tablo was filled with clots. Transmembrane pressures within the 90s. Blood returned and when attempting to drain the dialyzer, machine kept alarming to unclamp the yellow clamp. The clamp was open and the tablo help line was contacted. Nurse was unable to get a hold of anyone and was told to leave a message. Site tablo representative was called directly and instructed to turn off and power back on machine and try again. This resolved the issue. Later when the run was completed and tablo was disconnected the machine gave a message to call technical support. Before nurse could call, the message disappeared, and a heat cycle was completed. The alarm: saline clamp medium did not happen until after a new saline bag was required and changed out. 10 minutes later the machine started alarming saline clamp medium. It is unknown what potential harm there is when powering off a machine that is connected to the patient.
 
Event Description
No equipment issues or human factors interacting with equipment identified.
 
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Brand NameTABLO(R) HEMODIALYSIS SYSTEM
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 Key14013680
MDR Text Key288604739
Report Number14013680
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 03/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
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 FDA03/09/2022
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer04/05/2022
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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