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

Model Number	601000M
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During dialysis, blood leaking onto floor from top of dialyzer of sled machine.Cnc had flushed the system when the tmp rose prior to the blood leak.He also tightened red connector to dialyzer while rn was in the room and blood leak stopped momentarily.After a few minutes, you could see the connection loosen and blood leak re-appeared.

• Brand Name: TABLO D 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: 16504133
• Report Number: MW5115540
• Device Sequence Number: 6381871
• 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: 601000M
• Device Catalogue Number: PN-0004220
• Device Lot Number: D22000604
• 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