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 Problem Loss of consciousness (2418)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

The hospital staff reported that the patient is stable and has been receiving treatments at the outpatient clinic for over a week.Staff expressed that the patient missing a week of therapy and having a critically high potassium, blood sugar, and fluid overload led to the code.Tablo 400160 was returned to the treatment floor within a few days of occurrence.No issues have been reported regarding tablo 400160 since occurrence.Per charge nurse, the occurrence was not tablo related, but was related to high serum potassium.It was determined by dcl management the occurrence was not tablo related.No issues noted with production records.

Event Description

It was reported that within 15 minutes of therapy the patient became unresponsive and coded.No alarms occurred.The clinical staff initiated cpr, administered 600 ml of normal saline and contacted the emergency department.Blood was returned successfully.The patient was transported to saint elizabeth hospital.It was noted that the patient had a c-section on (b)(6) 2019 and was two weeks postpartum.The patient was also diagnosed with pneumonia a week prior to the event.The charge nurse noted that the patient last received dialysis at the clinic on 9/28/19 and had missed one week of therapy.The patient has a history of missing scheduled dialysis treatments.Post the event, the patient was alert and awaiting staffing for acute dialysis treatment at the hospital.Per the charge nurse, the occurrence was not device related, but was related to high serum potassium.

• 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: 9221938
• MDR Text Key: 163706993
• Report Number: 3010355846-2019-00008
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)190122
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PN-0003000
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/05/2019
• Date Manufacturer Received: 10/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2019
• 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): Hospitalization; Life Threatening
• Patient Age: 33 YR