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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Failure to Transmit Record (1521); Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2022
Event Type  malfunction  
Event Description
Patient on tablo went to print patient tablo report after run. Unable to locate patient. Assessed machine once heat was finished, machine not connected to wi-fi contacted personnel, not able to connect to wi-fi. Went to tub room to switch out devices only machine in room was currently doing a full chem. Amanda then gave further instructions to switch out the keys and tablo device with one of the tablo devices for hd in infusion center however, it made the machine unable to setup once key exchange. Changed key to original key which allowed new machine to work and switched out machines while going over limits and changes that were needed to be made on device on the phone.
 
Event Description
No equipment issues or human factors interacting with equipment identified.
 
Event Description
Patient on tablo went to print patient tablo report after run. Unable to locate patient. Assessed machine once heat was finished, machine not connected to wi-fi contacted personnel, not able to connect to wi-fi. Went to tub room to switch out devices only machine in room was currently doing a full chem. She then gave further instructions to switch out the keys and tablo device with one of the tablo devices for hd in infusion center however, it made the machine unable to setup once key exchange. Changed key to original key which allowed new machine to work and switched out machines while going over limits and changes that were needed to be made on device on the phone.
 
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Brand NameTABLO 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 Key14249826
MDR Text Key290400749
Report Number14249826
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 04/22/2022
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 FDA04/22/2022
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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