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

Model Number PN-0003000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/31/2021

Event Type  Injury  

Manufacturer Narrative

From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. Outset medical, inc. Field service engineer (fse) reviewed site system logs with a procedure date of (b)(6) 2021, and verified that there was no issue with the system which caused the patient event. The system correctly identified and triggered arterial pressure low alarm three hours into treatment; blood pump stopped and all other components responded accordingly. The console is operating as intended after the event. A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product.

Event Description

It was reported that the blood pump was stopped due to low arterial pressure alarm during patient's treatment. It was reported that the nurse did not attend or intervene for the low arterial pressure alarm and it went on for 20 minutes. Treatment was ended and patient's blood was discarded. The patient lost approximately 1 l of blood. Note 1: it was reported that the patient's venous needle became dislodged and the patient was transferred to the intensive care unit (icu), and was reported to be unstable. No further patient information is available. Based on internal review of the log file data, it is not believed that the tablo device caused this event, rather this is attributed to user error.

• Brand Name: TABLO X HEMODIALYSIS SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• Manufacturer (Section G): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• Manufacturer Contact: 6692318235
• MDR Report Key: 11378448
• MDR Text Key: 233520351
• Report Number: 3010355846-2021-00057
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190793
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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?

• Distributor Facility Aware Date: 02/01/2021
• Event Location: No Information
• Date Manufacturer Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2020
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/25/2021 Patient Sequence Number: 1