FDA Adverse Event Injury Summary report: N

TABLO HEMODIALYSIS SYSTEM

MDR report key: 21044652 · Received December 30, 2024

Report

Report Number: 3010355846-2024-00108
Event Type: Injury
Date Received: December 30, 2024
Date of Event: December 2, 2024
Report Date: December 30, 2024
Manufacturer: OUTSET MEDICAL, INC.
Product Code: KDI
PMA / PMN Number: K190793
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H3/H6: 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. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. OUTSET MEDICAL, INC. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SITE SYSTEM LOG WITH A PROCEDURE DATE ON (B)(6) 2024 AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. DUE DILIGENCE WAS COMPLETED, AND OUTSET WAS NOT ABLE TO CONFIRM CAUSALITY DUE TO LACK OF INFORMATION.

Description of Event or Problem · 0

IT WAS REPORTED THAT A 80-YEAR-OLD FEMALE PATIENT HAD A CARDIAC ARREST AFTER DIALYSIS TREATMENT ON TABLO. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AS PART OF MEDICAL INTERVENTION. NOTE: CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT EVENT. LAST REPORTED, PATIENT WAS IN CRITICAL CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1782559	TABLO HEMODIALYSIS SYSTEM	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	OUTSET MEDICAL, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR	Female	Required Intervention