MAUDE Adverse Event Report: BAJA FUR S.A. DE C.V. TABLO DIALYSIS MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number TABLO

Device Problem No Audible Alarm (1019)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/18/2023

Event Type  Injury  

Event Description

Pt on dialysis on tablo machine made by outset.Pt pulled needle out.Machine did not alarm.Physician found needle in bed with blood pooling.

• Brand Name: TABLO DIALYSIS MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAJA FUR S.A. DE C.V.
• MDR Report Key: 17019887
• MDR Text Key: 316210309
• Report Number: MW5117951
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American