MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Model Number PN-0003000

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

Patient Problem Cardiac Arrest (1762)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: a mock treatment was run on the tablo unit on 25jun2019 and no issues were noted with the device. Upon follow up with the clinical staff, this event is not suspected to be caused by the device. Rather this event is most likely a result of the patient's pre-existing conditions. Production records were reviewed for the unit identified and no issues noted. Log files from the treatment were reviewed and it was confirmed that no device issues were noted.

Event Description

It was reported that a patient experienced a cardiac event during treatment. The patient was approximately 3 hours into a 4 hour treatment. The staff used an external defibrillator on the patient, who was conscious when transported from the clinic to the hospital. The blood was returned with no issues noted. It was not suspected that tablo contributed to the event, rather, this event was likely related to the patient's pre-existing condition.

• Brand Name: TABLO HEMODIALYSIS SYSTEM
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 1830 bering drive; san jose CA 95112 4212
• Manufacturer Contact: jennifer mascioli-tudor ; 1830 bering drive; san jose, CA 95112-4212 ; 6692318235
• MDR Report Key: 8791483
• MDR Text Key: 151107080
• Report Number: 3010355846-2019-00006
• Device Sequence Number: 1
• Product Code: KDI
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PN-0003000
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 07/15/2019 Patient Sequence Number: 1