CELLEX SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for CELLEX SYSTEM manufactured by Therakos, Inc/mallinckrodt Pharmaceutical.

Event Text Entries

[181810355] Pulmonary emboli (pe) and a deep vein thrombosis (dvt) was diagnosed in a patient receiving extracorporeal photopheresis (ecp). Treatment via the callex system for bronchiolitis obliterans syndrome (bos). The patient went to an outlying emergency department with complaints of shortness of breath and cough that started one hour prior to arrival. No chest pain. +tachypneas. Ct scan with contrast suggestion of a right middle lobe pulmonary embolism. Groundglass infiltrates lung bases right side greater than left. Patient was initially treated with lovenox and methylprednisolone and transferred to bjc. Lovenox was changed to heparin drip. (b)(6) 2019 lower extremity ultrasound showed acute deep vein thrombosis in the right posterior tibial and peroneal veins. No evidence of dvt in the left leg. Ct with contrast repeated (b)(6) 2019 showed pulmonary embolism involving the loar, segmental, and subsegmental branches of the right main pulmonary artery. No evidence of right heart strain. Groundglass opecities within the lung bases, right greater than the left, favored to represent an infectious inflammatory etiology versus scarring in the setting of bilateral lung transplantation. The patient had received 15 ecp treatments prior to the pe / dvt event. The pe/dvt event took place eight days after the last ecp treatment. The event was not related to the catheter used for the purpose of performing ecp. The physician felt the event was possibly related to the research. This event is being reported in light of the fda safety alert sent february 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093400
MDR Report Key9774680
Date Received2020-02-28
Date of Report2020-02-25
Date of Event2019-11-14
Date Added to Maude2020-03-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELLEX SYSTEM
Generic NameSYSTEMS, PHOTOPHERESIS, EXTRACORPOREAL
Product CodeLNR
Date Received2020-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerTHERAKOS, INC/MALLINCKRODT PHARMACEUTICAL
Manufacturer AddressBEDMINSTER NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-02-28

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