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

Model Number 600825M

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Syncope/Fainting (4411); Thrombosis/Thrombus (4440)

Event Date 04/05/2024

Event Type  Injury  

Event Description

Patient using a tablo hemodialysis machine to run his hemodialysis at home.Machine ran very smoothly with no issues.At the end of the treatment the blood was returned, patient's blood pressure dropped and a 100ml saline bolus was required.This was pushed via a 100ml saline bolus button on the machine and a large blood clot approximately 3/4 of an inch or longer was observed moving through the venous line from the cartridge into the venous lumen of the catheter that was still attached to patient.This large blood clot went into the patient.Concern was expressed to tablo's 1-844-my-tablo.Patient had just been diagnosed that day with bilateral pulmonary embolisms post a stat echocardiogram and a stat cta on (b)(6) 2024 as patient had been presenting with symptoms of low blood pressure, shortness of breath, weakness, and collapse.This specific machine had been called in to tablo multiple times and worked on multiple occasions for blood pump issues.The blood pump was replaced x1 in this machine since being in service with this facility since (b)(6) 2024.Since replacement of the blood pump there have been a multitude of blood pump position errors reported to tablo as well as concerns with repair status and repair responses.Upon each concern the machine has been verified ready for treatment by tablo.

• Brand Name: OUTSET MEDICAL TABLO
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; san jose CA 95134
• MDR Report Key: 19105156
• MDR Text Key: 340308219
• Report Number: MW5153843
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 600825M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White