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

Model Number	601011M
Health Effect - Clinical Code	Cough (4457)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): OUTSET MEDICAL, INC.; san jose CA
• MDR Report Key: 16504121
• Report Number: MW5115539
• Device Sequence Number: 12357845
• Product Code: FJK
• UDI-Device Identifier: 00850001011211
• UDI-Public: (01)00850001011211
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American