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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 Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2022
Event Type  malfunction  
Event Description
Tablo machine was being difficult to use. Patient started on machine #(b)(4) and then had to be transferred to machine #(b)(4). The following alarms went off during treatment with machine #(b)(4): pre-treatment: blood cassette unloaded. Pre-treatment: blood pump position error. Treatment power fail recovery: blood pump rate. Post-treatment: dialyzer connectors not ready for drain. Post-treatment: low incoming water pressure recoverable. Post-treatment: acid connector not on rinse port. Over the course of troubleshooting several internal calls were made as well as a call to outset medical resulting in a work order being placed. Starting the next treatment on this patient took in excess of 4 hours, not including the time it takes to rinse and prepare machine for next treatment.
 
Event Description
Tablo machine was being difficult to use. Patient started on machine and then had to be transferred to another machine. The following alarms went off during treatment with first machine listed: pre-treatment: blood cassette unloaded, pre-treatment: blood pump position error, treatment power fail recovery: blood pump rate, post-treatment: dialyzer connectors not ready for drain, post-treatment: low incoming water pressure recoverable, post-treatment: acid connector not on rinse port. Over the course of troubleshooting several internal calls were made as well as a call to outset medical resulting in a work order being placed. Starting the next treatment on this patient took in excess of 4 hours, not including the time it takes to rinse and prepare machine for next treatment.
 
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 Key14013757
MDR Text Key288603735
Report Number14013757
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,Followup
Report Date 03/09/2022,03/03/2022
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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