FDA Adverse Event Death Summary report: N

QUANTUM HB/SO2 SENSOR (ACCESSORY TO QUANTUM WORKSTATION)

MDR report key: 19858859 · Received July 30, 2024

Report

Report Number
3003073153-2024-00029
Event Type
Death
Date Received
July 30, 2024
Date of Event
July 5, 2024
Report Date
July 30, 2024
Manufacturer
SPECTRUM MEDICAL LTD
Product Code
DRY
PMA / PMN Number
K202557
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MO, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

A PATIENT WAS PLACED ON ECMO (WORKSTATION (B)(6)) AT APPROXIMATELY 1600 HOURS ON (B)(6). THE INLET VENOUS SAT READING WAS 65-69% AND THE RETURN LINE (POST OXYGENATOR) WAS 95-100%. PERFUSIONIST NOTED BOTH INLET AND RETURN APPEARED TO BE BRIGHT RED. PERFUSIONIST COULD NOT LEAVE ROOM TO GET ANOTHER FIBER OPTIC CABLE. PERFUSIONIST TOOK THE VENOUS SENSOR AND PLACED IT ON THE RETURN LINE AND THE SATS CONTINUED TO READ 65-69% ALTHOUGH ARTERIAL SENSOR WAS READING 100%. CLEANED THE VENOUS SENSOR, REPOSITIONED AND USED A NEW PIPE CLAMP WITH NO CHANGE. A BLOOD GAS WAS DONE ON THE INLET BLOOD AND PO2 WAS OVER 500. THE PERFUSIONIST REALISED THAT THE PATIENT WAS UNINTENTIONALLY VENO-VENO CANNULATED RATHER THAN THE DESIRED VENO-ARTERIAL CANNULATION. DRAINAGE WAS SUPPOSED TO BE LEFT FEMORAL VEIN AND RETURN CANNULA RIGHT FEMORAL ARTERY. INSTEAD, THE RIGHT FEMORAL VEIN WAS UNINTENTIONALLY CANNULATED FOR THE RETURN LINE. DUE TO LITTLE HEART FUNCTION AND CANNULATION LOCATION ERROR, EXTREME RECIRCULATION SHOULD HAVE RESULTED IN THE ARTERIAL AND VENOUS SENSOR READING ALMOST THE SAME VALUE. ECMO WAS TERMINATED AT APPROXIMATELY 1900 HOURS AND THE PATENT DID NOT SURVIVE. PERFUSION REPORTS THE HCT WAS EXTREMELY LOW AROUND 9% STARTING THE RUN, BUT AFTER BLOOD ADMINISTRATION, HCT REBOUNDED TO 27% WITH NO CHANGE IN VENOUS SAT READINGS. A CAPTURE/SYNC WAS NOT PERFORMED. A FACTORY RESET WAS NOT PERFORMED. THE VENOUS SATURATION SENSOR APPEARED TO BE SIGNIFICANTLY INACCURATE ON THE INLET LINE ALTHOUGH THE PO2 WAS ACTUALLY VERY HIGH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
230240 QUANTUM HB/SO2 SENSOR (ACCESSORY TO QUANTUM WORKSTATION) BLOOD GAS MONITOR DRY SPECTRUM MEDICAL LTD HBS4-130

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Death QWS 12" ELITE (SERIAL NUMBER: (B)(6)).