FDA Adverse Event Death Summary report: N

TABLO CARTRIDGE

MDR report key: 19319444 · Received May 14, 2024

Report

Report Number
MW5154853
Event Type
Death
Date Received
May 14, 2024
Date of Event
February 16, 2024
Report Date
April 4, 2024
Manufacturer
OUTSET MEDICAL INC.
Product Code
FJK
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
501
Health Professional
Yes

Narratives

Description of Event or Problem · 0

CRITICAL PATIENT RECEIVING A 12 HOUR SLOW-LOW EFFICIENCY DIALYSIS (SLED) TREATMENT ON THE TABLO MACHINE SERIAL NUMBER: (B)(6). THE BLOOD TUBING CARTRIDGE: (B)(6), FAILED 4 TIMES DURING THE TREATMENT INCLUDING 1 EPISODE WHEN THE TABLO MACHINE WOULD NOT ALLOW THE PATIENTS BLOOD TO BE RETURNED CAUSING ESTIMATED BLOOD LOSS OF 300 ML'S AND REPEATED DELAYS IN CARE OF THIS CRITICAL ICU (INTENSIVE CARE UNIT) PATIENT. THE INTERRUPTION TO THIS CRITICAL PATIENT¿S DIALYSIS TREATMENT AND BLOOD LOSS DUE TO REPEATED FAILED CARTRIDGES X 4 IS NOT EXPECTED TO OCCUR DURING A DIALYSIS TREATMENT. IT IS UNKNOWN AS TO WHY THE MACHINE WOULD NOT ALLOW FOR THE PATIENT¿S BLOOD TO BE RETURNED OR WHY THE CARTRIDGES FAILED. THERE HAVE BEEN NUMEROUS OTHER OCCURRENCES I HAVE LISTED BELOW WITH THE SPACE GIVEN. I SPOKE WITH ANOTHER HOSPITAL ACUTE DIALYSIS PROGRAM WHO ALSO USES THE TABLO MACHINES AND CARTRIDGES, THEY HAVE HAD 57 FAILED CARTRIDGES SO FAR THIS YEAR. ONE FAILED CARTRIDGE THE PATIENT¿S BLOOD BURSTED OUT AROUND THE ARTERIAL BLOOD LINE MONITOR BLOOD LN THE MIDDLE OF THE TREATMENT. THIS CONTAMINATED THE PATIENT¿S BLOOD SO IT COULD NOT BE RETURNED. THERE ARE MANY OTHER TYPES OF OCCURRENCES THAT THIS OTHER HOSPITAL HAS EXPERIENCED. THESE TABLO MACHINES WERE ORIGINALLY DESIGNED FOR HOME DIALYSIS PATIENT¿S. IF A HOME PATIENT WARE TO EXPERIENCE THE SAME PROBLEMS THAT WE ARE HAVING WITH THESE MACHINES AND CARTRIDGES, I SEE THIS AS A HUGE RISK TO PATIENT SAFETY. REFERENCE REPORTS: MW5154851, MW5154852, MW5154854, MW5154855.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1102841 TABLO CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK OUTSET MEDICAL INC.

Patients

Seq Age Sex Outcome Treatment
1 36 YR Male Death| L