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

Model Number PN-0003000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Blood Loss (2597)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

Console was tested pre-treatment as part of set up and no issues were noted.The facility investigation concluded that issues observed were related to the catheter placement and patient anatomy and not device related.The tablo device performed as intended.A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product event.

Event Description

It was reported that the patient clotted off while undergoing treatment on tablo four times over a three-day period.Blood loss was estimated to be 1 liter total.Treatments were ended each time due to air getting into the arterial line.Later investigation by hospital management revealed that this was due to poor catheter placement and patient anatomy challenges.The nephrologist intentionally chose to retry treatment each time instead of fixing the catheter.The patient condition is stable / improving, and the patient is tolerating continued dialysis.It was concluded that the tablo device performed as intended.

• Brand Name: TABLO HEMODIALYSIS SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 1830 bering drive; san jose CA 95112 4212
• Manufacturer (Section G): OUTSET MEDICAL, INC.; 1830 bering drive; san jose CA 95112 4212
• Manufacturer Contact: 6692318235
• MDR Report Key: 9690887
• MDR Text Key: 178529925
• Report Number: 3010355846-2020-00013
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00852221011112
• UDI-Public: (01)00852221011112(11)181017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other