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

Model Number	PN-0005643
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Nearing end of sled (sustained low-efficiency dialysis) treatment, top portion of sled dialyzer leaked.Approx 400cc blood into the floor.Sled did not alarm.Lure lock was checked and secure, treatment resumed and flush started.Treatment continued for 10 minutes before the tmp became too high and forced to stop the treatment and return blood 30 minutes early.Pt had been given heparin bolus via sled for this treatment.Pt has been on sled multiple times now and the filter has clogged/clotted multiple times per treatment.Fda safety report id# (b)(4).

• Brand Name: TABLO CARTRIDGE
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): OUTSET MEDICAL, INC.; san jose CA 95134
• MDR Report Key: 15589112
• Report Number: MW5112557
• Device Sequence Number: 2328569
• 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): 10/06/2022

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: PN-0005643
• 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: 10/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White