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

Model Number PN-0004220-A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Dizziness (2194); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

H3/h6: from the information provided, there is no indication that there was any device malfunction or nonconformance, that contributed to the reported event.For the reported event of blood leak noticed from arterial end of dialyzer, there is no sensor to indicate a leak, only visual observation.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.Tablo user manual has the following warning: ensure all connections are secure before use and monitor for leaks regularly during patient use.Blood loss can result if connections are not secure and during the dialysis treatment, monitor the lines and check for leaks.Machine alarms may not occur in every blood loss situation.Outset medical, inc.Technical support engineer (tse) reviewed site system log with a procedure date of (b)(6) 2024 and verified that there was no issue with the system which caused the patient event.The dialyzer and cartridge were discarded; therefore, root cause of the event was not able to be confirmed, however is it not suspected to be product related.A review of production records for this cartridge lot did not note any related manufacturing nonconformances that would contribute to this event.

Event Description

It was reported that the patient complained of light headedness and cramping near end of treatment; patient was given 400cc saline bolus and immediately after blood leak was noticed from arterial end of dialyzer.Blood on floor was about 200+ ml.Patient was given a unit red blood cell and the patient was stable after the incident.

• Brand Name: TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE
• 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: lance mattoon ; 3052 orchard drive; san jose, CA 95134 ; 6692318200
• MDR Report Key: 19088360
• MDR Text Key: 339925644
• Report Number: 3010355846-2024-00099
• Device Sequence Number: 1
• Product Code: KDI
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Model Number: PN-0004220-A
• Device Catalogue Number: 250326
• Device Lot Number: M23257L03S01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention