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

Model Number	PN-0003000
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a history of cardiac stenosis coded twice during dialysis treatment on tablo.The care personnel initiated cardiopulmonary resuscitation (cpr), and the patient was revived and was stable.During the second code, the care personnel attempted to return the blood and end the treatment; however, it was reported that the tablo touchscreen froze.The nurse disconnected the patient from the tablo device and there was estimated 240 ml of blood loss.The patient was revived and was stable post-treatment.Based on the available information, it is unknown if the code event was related to the patient¿s underlying condition; therefore, this event is being reported as a serious injury.
Additional Manufacturer Narrative
An investigation conducted by outset technical team via log review confirmed that the user manually stopped the blood pump at 66 and half minutes into a two and half-hour treatment.The treatment was ended, which is when the ¿new saline bag required¿ alarm was triggered.By this time, 800 ml of saline was already used by the site and there was not enough saline to return the blood, hence ¿alarm saline bag required¿ was prompted.It was noted that 400 ml of saline was delivered in the six minutes prior to the alarm new saline bag required.The outset technical team concluded that this strongly indicates that the patient was in distress prior to the alarm.It could not be confirmed if the graphic user interface (gui) went black at this point.A field service engineer (fse) replaced the touchscreen on the system.A comprehensive dhr (device history record) review was performed.There were no non-conformances noted upon review of the dhr for the console and it was confirmed that this console met all inspections and test criteria.Prior to final release and distribution to customers, all tablo consoles are inspected, tested and verified through in-process inspection and testing, followed by a quality inspection after manufacturing.

• Brand Name: TABLO X HEMODIALYSIS SYSTEM
• Common Device Name: 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: 12619848
• Report Number: 3010355846-2021-00071
• Device Sequence Number: 11086655
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)190509
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: PN-0003000
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1