Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO(R) CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OUTSET MEDICAL, INC. TABLO(R) CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number PN-0008544
Patient Problem Insufficient Information (4580)
Event Date 03/11/2024
Event Type  malfunction  
Event Description
Patient received approximately 30 minutes when alarms started stating "venous pressure low".Registered nurse (rn1) assessed cartridge noting bubbles in drip chamber.Rn1 attempted to remove bubbles by aspirating with 10ml syringe the bubbles.Unsuccessful, rn1 asked rn2 to assist with the situation when rn2 noticed blood in the transducer line."returned blood, but not all the blood".Changed out cartridge and restarted treatment.Manufacturer response for set, tubing, blood, with and without anti-regurgitation valve, tablo(r) cartridge (per site reporter).Outset medical has been notified in the past of this issue and they don't usually respond or they delay investigation.User facility has had multiple reports on this item in the last years with no resolve.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TABLO(R) CARTRIDGE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
OUTSET MEDICAL, INC.
3052 orchard drive
san jose CA 95134
MDR Report Key18939967
MDR Text Key338122010
Report Number18939967
Device Sequence Number1
Product Code FJK
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
Report Date 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPN-0008544
Device Catalogue NumberPN-0004220
Device Lot NumberM23166L2S01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/13/2024
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/20/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-