FDA Adverse Event Death Summary report: N

TABLO HEMODIALYSIS SYSTEM

MDR report key: 10570988 · Received September 22, 2020

Report

Report Number: 3010355846-2020-00028
Event Type: Death
Date Received: September 22, 2020
Date of Event: August 31, 2020
Report Date: September 22, 2020
Manufacturer: OUTSET MEDICAL, INC.
Product Code: KDI
UDI-DI: 00850001011112
PMA / PMN Number: K190793
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, 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. SYSTEM ENGINEER HAS REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020. NO RELATED SYSTEM ALARMS WERE FOUND TO HAVE OCCURRED DURING TREATMENT. THE DEVICE IS FUNCTIONING POST TREATMENT. 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 SIX HOURS INTO DIALYSIS TREATMENT, THE PATIENT, WHO WAS COVID POSITIVE AND WAS NOT A CHRONIC DIALYSIS PATIENT EXPIRED DURING TREATMENT. IT WAS REPORTED THAT THE PATIENT WAS ELDERLY, AND HAD MULTIPLE CO-MORBIDITIES. THE TREATING TEAM ATTRIBUTED THE EVENT TO THE PATIENT'S PRE-EXISTING CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1032920	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