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

Device Problems Partial Blockage (1065); Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

Patient¿s mother repeated entry/exits into room interrupted treatment device troubleshooting by causing staff to stop troubleshooting so that patient could enter/exit the room.Patient was experiencing high % trach leak causing desaturation and experiencing tablo treatment tubing obstruction causing interruption of hd.Repeated entry and exit into patient's room while troubleshooting devices could have caused patient deterioration related to device issues and/or dislodging of iv/airway equipment from moving devices to let mother in and out.Since mother voluntarily left room while issues were actively being troubleshooted, staff asked that patient mother await outside of unit upon trying to reenter while the issues with patient devices were addressed and solved and patient became stable.Visitor should receive instruction on the potential safety issues caused by repeated exit/entry during staff troubleshooting and during patient deterioration.

Event Description

No equipment issues or human factors interacting with equipment identified.

• Brand Name: TABLO 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
• MDR Report Key: 14249912
• MDR Text Key: 290385335
• Report Number: 14249912
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10220 DA
• Patient Sex: Female
• Patient Weight: 82 KG