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

Model Number PN-0004220

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

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

Event Date 11/11/2022

Event Type  malfunction  

Event Description

Seven and a half (7.5) hours into sled(sustained low-efficiency dialysis), dialysis, rn noted clots in the filter and the high pressure alarm sounded just prior to the dialyzer leaking blood at the top.Leak caught quickly - blood was not able to be returned.D2200604 lot cartridge removed and rn attempted to start 2nd treatment, machine would not allow.Another machine was obtained and treatment started and completed successfully.A delay of 1.75 hours occurred between the leak and getting the new equipment started.The rn involved has sled competencies and had done multiple sled procedures successfully prior to this incident.No patient injury was noted.

• Brand Name: TABLO CARTIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): OUTSET MEDICAL, INC.
• MDR Report Key: 16372941
• MDR Text Key: 309597462
• Report Number: MW5114920
• Device Sequence Number: 1
• Product Code: KDI
• 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: 02/09/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PN-0004220
• Device Catalogue Number: PN-0004220
• Device Lot Number: D2200604
• 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: 175 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White