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

Model Number PN-0005644

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 08/16/2022

Event Type  Injury  

Manufacturer Narrative

H3/h6: the cartridge has been returned for product evaluation; however, no conclusions / root causes were identified.A supplemental mdr will be filed if more information is received.This mdr is being filed after the associated complaint was reviewed under retrospective review and reassessed as reportable.

Event Description

It was reported that there was arterial pod separation one hour and 30 minutes into patient treatment on tablo and no alarm occurred before and during the incident.There was an estimate of 400 - 500 ml blood loss.It was noted that the patient is feeling sick and may need transfusion.Note: user states the patient may need blood transfusion; however, this cannot be confirmed, other than that patient was noted as in stable condition.

• 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: 17515604
• MDR Text Key: 321046981
• Report Number: 3010355846-2023-00084
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 10850001011218
• UDI-Public: (01)10850001011218(17)231130(10)D2213114
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: PN-0005644
• Device Lot Number: D2213114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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