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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 Application Program Problem (2880); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2022
Event Type  malfunction  
Event Description
The patient's arterial catheter was clamped per instructions. The tablo computer alarmed saying the patient line was not clamped. I ensured the clamp was closed. I then attempted to continue. The same alarm was sounded. I then manually held down the clamp tightly. The tablo attempted to send the blood back to the patient, but the blood was not being pulled or pushed through the line, thus not returning to the patient, despite the computer "showing" it was being returned. I attempted to manually return the blood. The tablo then sounded an alarm and force shut down. When the tablo turned back on, it showed a complete cycle. Due to time and inability to get the blood manually returned i notified the provider the blood in the line was not returned to the patient. He instructed to draw morning labs and check hemoglobin. Vitals were stable. Hemoglobin (hgb) did have a drop from 7. 5 to 6. 8. The provider ordered 1 unit of blood to be given. " nurse had this issue two times. The first she called rn and they discovered the nurse had the wrong clamp clamped. The nurse was educated and instructed to use the clamp on the patient catheter. The next run the nurse clamped the correct clamp but the machine gave the same alarm. The machine was acting like the blood was being returned to the patient but in fact, was not. They tried to manually give back blood but eventually the machine forced a shut down and the blood was wasted. Due to the hgb drop, blood products were needed. Tablo machine was taken out of service to be looked at. There is no associated service report from tablo for reference.
 
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 Key14013725
MDR Text Key288603424
Report Number14013725
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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