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 Blood Loss (2597)

Event Date 09/25/2020

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 tablo hemodialysis system user manual includes, but are not limited to, verifying that all tubing and connections are secured and closely monitored to prevent loss of blood or entry of air into the extracorporeal circuit or errors in the ultrafiltration control system.The patient may require blood transfusion or other medical intervention to prevent respiratory or cardiac complications if these occur.Outset medical, inc.Tablo program specialist (tps) evaluated the tablo system for procedure date of (b)(6) 2020.Tps observed that there was a large amount of air being sucked into the system causing these issues and requiring the treatment to end.The device is functioning post treatment.A review of production records for this unit did not note any related manufacturing nonconformances that would contribute to this event.

Event Description

It was reported that a patient was under a medical induced coma while undergoing dialysis treatment on a tablo system.The patient was stable before, during and after treatment.During treatment an alarm was triggered, alerting of air in the venous bloodline.Treatment was ended and the nurse was unable to return the patient's blood.Blood loss was estimated to be approximately 214 ml.The nurse setup for another treatment on the same device with a new cartridge.Again, the same alarm occurred, and the second blood loss was estimated to be approximately 214 ml; with a total blood loss of approximately 428 ml.Treatment was completed on a non-tablo machine.It was reported by the hospital staff that the method used to troubleshoot the patient's catheter may have contributed to the air in the system that caused the alarms.It is not believed that the tablo device caused the event; rather, the treating staff attributed the event to use error.

• 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: 10708443
• MDR Text Key: 212266466
• Report Number: 3010355846-2020-00029
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)190407
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/25/2020
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2019
• 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): Life Threatening