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

Model Number PN-0005643

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2022

Event Type  malfunction  

Event Description

Dialysis treatment started.Alarm detected air in blue line.Air was aspirated and treatment was resumed.The technician then noticed that there was blood leaking from the cartridge.Technician took the setup down and setup for the treatment with new supplies.Upon inspection of the used cartridge, a hole was noted in the line that connects to the blood pump loop segment.Technician saved the cartridge and notified the supervisor.They were unable to return the blood to the patient due to risk of contamination.This particular patient has hemoglobin (hgb) that normally runs around 13.

Event Description

Dialysis treatment started.Alarm detected air in blue line.Air was aspirated and treatment was resumed.The technician then noticed that there was blood leaking from the cartridge.Technician took the setup down and setup for the treatment with new supplies.Upon inspection of the used cartridge, a hole was noted in the line that connects to the blood pump loop segment.Technician saved the cartridge and notified the supervisor.They were unable to return the blood to the patient due to risk of contamination.This particular patient has hemoglobin (hgb) that normally runs around 13.

• Brand Name: TABLO(R) CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• MDR Report Key: 15707749
• MDR Text Key: 302772254
• Report Number: 15707749
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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
• Device Model Number: PN-0005643
• Device Catalogue Number: PN-0004220
• Device Lot Number: D2211013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Female