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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
Model Number PN-0003000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Date 10/05/2019
Event Type  Injury  
Manufacturer Narrative
The hospital staff reported that the patient is stable and has been receiving treatments at the outpatient clinic for over a week. Staff expressed that the patient missing a week of therapy and having a critically high potassium, blood sugar, and fluid overload led to the code. Tablo 400160 was returned to the treatment floor within a few days of occurrence. No issues have been reported regarding tablo 400160 since occurrence. Per charge nurse, the occurrence was not tablo related, but was related to high serum potassium. It was determined by dcl management the occurrence was not tablo related. No issues noted with production records.
 
Event Description
It was reported that within 15 minutes of therapy the patient became unresponsive and coded. No alarms occurred. The clinical staff initiated cpr, administered 600 ml of normal saline and contacted the emergency department. Blood was returned successfully. The patient was transported to saint elizabeth hospital. It was noted that the patient had a c-section on (b)(6) 2019 and was two weeks postpartum. The patient was also diagnosed with pneumonia a week prior to the event. The charge nurse noted that the patient last received dialysis at the clinic on 9/28/19 and had missed one week of therapy. The patient has a history of missing scheduled dialysis treatments. Post the event, the patient was alert and awaiting staffing for acute dialysis treatment at the hospital. Per the charge nurse, the occurrence was not device related, but was related to high serum potassium.
 
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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.
1830 bering drive
san jose CA 95112 4212
Manufacturer (Section G)
OUTSET MEDICAL, INC.
1830 bering drive
san jose CA 95112 4212
Manufacturer Contact
6692318235
MDR Report Key9221938
MDR Text Key163706993
Report Number3010355846-2019-00008
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPN-0003000
Device Catalogue NumberPN-0003000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date10/05/2019
Event Location No Information
Date Manufacturer Received10/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/22/2019 Patient Sequence Number: 1
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