MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO HMODIALYZER; DIALYZER, HIGH PERMABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number TABLO CONSOLE

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2020

Event Type  Injury  

Event Description

During routine dialysis treatment tablo dialyzer powered down.Patient¿s blood returned via hand crank.Dialysis treatment needed to be stopped related to equipment shut down.No signs/symptoms of pain or adverse effects.Required intervention to prevent patient from blood loss.Fda safety report id # (b)(4).

• Brand Name: TABLO HMODIALYZER
• Type of Device: DIALYZER, HIGH PERMABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.
• MDR Report Key: 9641568
• MDR Text Key: 176973874
• Report Number: MW5092571
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLO CONSOLE
• Device Catalogue Number: PN-003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 60