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

Model Number PN-0005643

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2022

Event Type  malfunction  

Event 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
• 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: 15589112
• MDR Text Key: 301733153
• Report Number: MW5112557
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00850001011211
• UDI-Public: (01)00850001011211
• 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 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White