FDA Adverse Event Death Summary report: N

TABLO X HEMODIALYSIS SYSTEM

MDR report key: 14190695 · Received April 22, 2022

Report

Report Number: 3010355846-2022-00074
Event Type: Death
Date Received: April 22, 2022
Date of Event: May 31, 2020
Report Date: April 22, 2022
Manufacturer: OUTSET MEDICAL, INC.
Product Code: KDI
PMA / PMN Number: K190793
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION OR NONCONFORMANCE THAT CONTRIBUTED TO THE REPORTED EVENT. MULTIPLE FOLLOW UP ATTEMPTS TO GATHER ADDITIONAL INFORMATION FROM THE INITIAL REPORTER WERE UNSUCCESSFUL. 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. TECHNICAL TEAM HAS REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020 AND (B)(6) 2020, AND VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED.

Description of Event or Problem · 0

HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT CODED DURING TREATMENT AND THAT BLOOD WAS LEAKING FROM THE BLUE DIALYZER CONNECTOR. THE PATIENT EXPIRED THE NEXT DAY. THE CAUSE OF THE BLOOD LEAKING FROM THE BLUE DIALYZER CONNECTOR WAS REPORTED TO BE DUE TO OPERATOR ERROR. THE CAUSE OF DEATH AND RELATIONSHIP BETWEEN THE DEATH AND TABLO WAS NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
199838	TABLO X HEMODIALYSIS SYSTEM	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	OUTSET MEDICAL, INC.	TABLO X HEMODIALYSIS SYSTEM

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Death