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Spectrum Medical Ltd

Manufacturer

CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS

FDA Adverse Event
Malfunction ·SPECTRUM MEDICAL S.R.L.·Product code KFM·August 2, 2024

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·October 20, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·October 30, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Malfunction ·SPECTRUM MEDICAL S.R.L.·Product code DTR·November 21, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Malfunction ·SPECTRUM MEDICAL S.R.L.·Product code DTR·November 25, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·December 17, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 W

FDA Adverse Event
Malfunction ·SPECTRUM MEDICAL S.R.L.·Product code DTR·November 21, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 W

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·December 10, 2025

QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code KFM·October 7, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·November 20, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Malfunction ·SPECTRUM MEDICAL S.R.L.·Product code DTR·November 25, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·December 9, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·October 28, 2025

QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGR

FDA Adverse Event
Malfunction ·SPECTRUM MEDICAL S.R.L.·Product code KFM·September 11, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·October 28, 2025

QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS

FDA Adverse Event
Death ·SPECTRUM MEDICAL S.R.L.·Product code KFM·December 24, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·October 30, 2025

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Malfunction ·SPECTRUM MEDICAL S.R.L.·Product code DTR·November 7, 2025

QUANTUM PERFUSION DUAL LUMEN CANNULA DL27

FDA Adverse Event
Malfunction ·SPECTRUM MEDICAL S.R.L.·Product code DWF·September 29, 2025