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 Problem Death (1802)

Event Date 08/31/2020

Event Type  Death  

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.Potential adverse events in the instructions for use (ifu) with the tablo system includes, but are not limited to, other, more serious, complications arising from dialysis, such as hemorrhage, air embolism, acidosis, alkalosis or hemolysis, can cause serious patient injury or death.Outset medical, inc.System engineer has reviewed site system logs with a procedure date of (b)(6) 2020.No related system alarms were found to have occurred during treatment.The device is functioning post treatment.A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product event.

Event Description

It was reported that six hours into dialysis treatment, the patient, who was covid positive and was not a chronic dialysis patient expired during treatment.It was reported that the patient was elderly, and had multiple co-morbidities.The treating team attributed the event to the patient's pre-existing condition.

• 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
• Manufacturer (Section G): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• Manufacturer Contact: 6692318235
• MDR Report Key: 10570988
• MDR Text Key: 208089332
• Report Number: 3010355846-2020-00028
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)190419
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PN-0003000
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/31/2020
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death