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

Model Number PN-0003000

Device Problem Use of Device Problem (1670)

Patient Problem Blood Loss (2597)

Event Date 05/18/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: log files of the device were reviewed by outset medical personnel. A device issue related to a blood leak sensor component failure was identified; however, was not the reason for the adverse event. The nurse had attempted a manual blood return; however, it was unsuccessful due to user error. The event of blood loss is attributed to this user error.

Event Description

It was reported that an end treatment alarm was observed. The patient experienced a blood loss of approximately 440 ml (300 ml in dialyzer and 140 ml in cartridge). Upon further review, it was determined that the nurse had not completed the manual blood return correctly. Therefore, this event is not device related, rather attributed to user error.

• 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 (Section G): 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: 8688739
• MDR Text Key: 147649919
• Report Number: 3010355846-2019-00005
• 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

• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• 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: 06/11/2019 Patient Sequence Number: 1