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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 Problems Loss of consciousness (2418); Loss Of Pulse (2562)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
Console functionality was tested pre-treatment as part of set up and no issues were noted. There is no indication that this is a product issue. The patient has pre-existing conditions and had a history of missed treatments. A review of production records for this unit did not note any manufacturing non-conformances that would contribute to a product event.
 
Event Description
It was reported that a patient lost consciousness and coded five minutes into dialysis treatment. Blood was returned and an additional 400 ml saline was administered. The patient was revived and transported to a hospital. There were no patient symptoms reported prior to coding. The patient was released from the hospital on (b)(6) 2019 and received successful dialysis treatment on (b)(6) 2019. It was noted that the patient's last treatment prior to the event was on (b)(6) 2019; the patient was (b)(6)kg over the estimated dry weight (edw) and per medics, blood sugar was 290. This same patient experienced a similar event as reported in mdr 3010355846-2019-00008. It is believed that the event was related to the patient's condition and missed treatments and not due to the tablo product.
 
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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 Key9531381
MDR Text Key177831324
Report Number3010355846-2019-00011
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,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPN-0003000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2019
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: 12/30/2019 Patient Sequence Number: 1
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