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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 Inaccurate Flow Rate (1249); Obstruction of Flow (2423); Protective Measures Problem (3015)
Patient Problems Low Blood Pressure/ Hypotension (1914); Ventilator Dependent (2395); Confusion/ Disorientation (2553)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
3 tablo pump failures leading to delay of care. Adult morbidly obese female pt admitted with acute kidney injury requiring emergent dialysis. Pt alert, confused, requiring bilevel positive airway pressure; hypotensive requiring levophed continuous medication drip, dialysis catheter in right internal jugular. On initial start of continuous renal replacement therapy (crrt) the tablo machine displayed alarm "bypass valve failure", outset medical notified, taken out of service, case # assigned. With second tablo machine, first alarm displayed "high vascular pressure", multiple attempts at troubleshooting line including flushing line, switching blue/red lines, repositioning pt. Vascath was found to be clotted and required instillation of heparin and heparin continuous drip to be started, treatment paused for approximately 3 hours waiting for labs and heparin to be dosed to by pharmacy. Second alarm from same tablo machine displayed "water module failure". Machine removed from pt room, outset notified, able to troubleshoot over the phone and resolve problem, third tablo machine displayed alarm of "incorrect blood pump rate"" outset medical notified, instructed to take machine out of service, case # assigned. 4th tablo machine brought to bedside and was able to initiate treatment, total of 6 cartridge/filter changes occurred. Pt received approximately 1. 5 hours of crrt throughout the 12-hour shift. Potassium remained critically high, with minimal urine output throughout night. Recommend having these issues resolved sooner rather than later as it is delaying care for critically ill patients. These errors are not being able to be troubleshooted by the bedside rn. How, if possible, can we prevent/limit these troubleshooting alarms from recurring so often?".
 
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 Key14013730
MDR Text Key288604717
Report Number14013730
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
1 Patient was 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

Patient Treatment Data
Date Received: 04/05/2022 Patient Sequence Number: 1
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