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

Model Number 601011M

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem Cough (4457)

Event Date 01/19/2023

Event Type  Injury  

Event Description

Patient on sedation holiday and spontaneous breathing trial on vent receiving dialysis.He had a strong cough and the sled machine clotted and leaked at top of filter.Treatment completed based on the tablo hub report.In intensive care unit end stage renal disease, hyperkalemia, type 2 diabetes mellitus; asthma, dependence on renal dialysis, obesity, nicotine dependence.

• Brand Name: TABLO D CARTRIDGE SLED CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): OUTSET MEDICAL, INC.; san jose CA
• MDR Report Key: 16504121
• MDR Text Key: 311040462
• Report Number: MW5115539
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 601011M
• Device Catalogue Number: PN-0004220
• Device Lot Number: D2200604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American