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

Model Number TABLO X HEMODIALYSIS SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 05/29/2020

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.Potential adverse events in the instructions for use (ifu) with the tablo system includes, but are not limited to, clotting may be evidenced by high venous pressure, dark blood in lines or drip chambers, visible clots in the drip chamber or dialyzer.Failure to respond to clotting may expose the blood circuit to sustained high pressures leading to a possible blood leak or hemolysis (blood cell damage).Outset medical inc.Field service engineer (fse) was dispatched to the customer site to further investigate the reported issue.The reported issue was not reproduced during field evaluation, and unit was deemed operable.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 a patient with vessel stenosis and a permanent catheter experienced loss of consciousness three hours into treatment, treatment was ended.During treatment there was increase in venous pressure that could not be overcome, and nurse was unable to move past the high venous pressure; subsequently, patient loss approximately 200 cc of blood due to possible clotting.The nurse administered approximately 500 cc fluid bolus through the arterial catheter port as the venous catheter port was very difficult to flush or aspirate.It was noted that the nurse did not flush the system at any time before to attempt to visualize the dialyzer or venous drip chamber (vdc).The patient recovered and is stable.Additional information was received from outset medical inc.Clinical manager on 6/18/2020, which indicated that the site dialysis director presumes the patient simply clotted and the event was not attributed to a product malfunction.

• Brand Name: TABLO HEMODIALYSIS SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 1830 bering drive; san jose CA 95112 4212
• Manufacturer (Section G): OUTSET MEDICAL, INC.; 1830 bering drive; san jose CA 95112 4212
• Manufacturer Contact: 6692318235
• MDR Report Key: 10189009
• MDR Text Key: 201060674
• Report Number: 3010355846-2020-00021
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)190821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160866
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLO X HEMODIALYSIS SYSTEM
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention