FDA Adverse Event Death Summary report: N

TABLO HEMODIALYSIS SYSTEM

MDR report key: 11024575 · Received December 16, 2020

Report

Report Number: 3010355846-2020-00034
Event Type: Death
Date Received: December 16, 2020
Date of Event: November 18, 2020
Report Date: December 16, 2020
Manufacturer: OUTSET MEDICAL, INC.
Product Code: KDI
UDI-DI: 00850001011112
PMA / PMN Number: K190793
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

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, OTHER, MORE SERIOUS, COMPLICATIONS ARISING FROM DIALYSIS, SUCH AS HEMORRHAGE, AIR EMBOLISM, ACIDOSIS, ALKALOSIS OR HEMOLYSIS, CAN CAUSE SERIOUS PATIENT INJURY OR DEATH. OUTSET MEDICAL, INC. FIELD SERVICE ENGINEER (FSE) REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020, AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. THE CONSOLE IS OPERATING AS INTENDED AFTER THE EVENT. A REVIEW OF PRODUCTION RECORDS FOR THIS UNIT DID NOT NOTE ANY MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO A PRODUCT EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT CODED AND EXPIRED DURING TREATMENT. PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, IT IS NOT BELIEVED THAT THE TABLO DEVICE CONTRIBUTED TO THE PATIENT EXPIRATION. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1484552	TABLO HEMODIALYSIS SYSTEM	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	OUTSET MEDICAL, INC.	PN-0003000		00850001011112

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death