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 Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Console functionality was tested pre-treatment as part of set up and no issues were noted.There is no indication that this is a product issue.The patient has pre-existing conditions and had a history of missed treatments.A review of production records for this unit did not note any manufacturing non-conformances that would contribute to a product event.

Event Description

It was reported that a patient lost consciousness and coded five minutes into dialysis treatment.Blood was returned and an additional 400 ml saline was administered.The patient was revived and transported to a hospital.There were no patient symptoms reported prior to coding.The patient was released from the hospital on (b)(6) 2019 and received successful dialysis treatment on (b)(6) 2019.It was noted that the patient's last treatment prior to the event was on (b)(6) 2019; the patient was (b)(6)kg over the estimated dry weight (edw) and per medics, blood sugar was 290.This same patient experienced a similar event as reported in mdr 3010355846-2019-00008.It is believed that the event was related to the patient's condition and missed treatments and not due to the tablo product.

• 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: 9531381
• MDR Text Key: 177831324
• Report Number: 3010355846-2019-00011
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00852221011112
• UDI-Public: (01)00852221011112(11)190206
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2019

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: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2019
• 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: 32 YR
• Patient Weight: 100