MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number PN-0006000

Device Problems No Audible Alarm (1019); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

During sled treatment, blood dripped from top of filter to floor.Threads were tightened, blood continued to drip.Machine was not alarming.Estimate 30cc blood/fluid loss.The tmp was climbing and there was barely a difference in the tmp before it started leaking in the floor.Fda safety report id# (b)(4).

• Brand Name: TABLO CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): OUTSET MEDICAL, INC.; san jose CA 95134
• MDR Report Key: 15589134
• MDR Text Key: 301730631
• Report Number: MW5112558
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PN-0006000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White