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
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3010355846-2023-00084
• Device Sequence Number: 5536125
• Product Code: KDI
• UDI-Device Identifier: 10850001011218
• UDI-Public: (01)10850001011218(17)231130(10)D2213114
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K190793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/11/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown