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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS THERAKOS CELLEX PHOTOPHERESIS SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
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MALLINCKRODT PHARMACEUTICALS THERAKOS CELLEX PHOTOPHERESIS SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL Back to Search Results
Model Number CELLEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Facial Nerve Paralysis (1846); Weakness (2145); Low Oxygen Saturation (2477); Ambulation Difficulties (2544)
Event Date 04/14/2020
Event Type  Injury  
Event Description
Patient had photopheresis treatment done with therakos cellex instrument.Patient was baseline when arrived in clinic.Patient walked into clinic.At end of procedure patient was unable to sit self up out of bed.Oxygen sat was noted to be in 60's and left arm noted to be flaccid and patient unable to lift arm.Notable weakness in left leg.Higher concentrations of oxygen delivered until o2 normal.Rapid response called.Patient unable to smile, patient alert and oriented.Patient was transferred to emergency room as stroke alert workup.Product not available to be sent, but card with procedure information will be sent to therakos.Fda safety report id #: (b)(4).
 
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Brand Name
THERAKOS CELLEX PHOTOPHERESIS SYSTEM
Type of Device
SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
Manufacturer (Section D)
MALLINCKRODT PHARMACEUTICALS
MDR Report Key9977051
MDR Text Key188559484
Report NumberMW5094184
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCELLEX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/17/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age76 YR
Patient Weight62
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