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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERAKOS, INC. / MALLINCKRODT PHARMACEUTICAL CELLEX SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

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THERAKOS, INC. / MALLINCKRODT PHARMACEUTICAL CELLEX SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Tachycardia (2095); Hypoxia in Utero (2210); Wheezing (4463)
Event Date 08/03/2020
Event Type  Injury  
Event Description
Pulmonary emboli (pe) was diagnosed in a pt receiving extracorporeal photopheresis (ecp) treatment via the cellex system for bronchiolitis obliterans syndrome (bos).The pt developed acute dyspnea in the middle of the night.Accompanied by chest tightness.Wheezing, and dyspnea with minimal exertion.Pt went to local emergency dept and found to be tachycardic and hypoxemic that resolved with oxygen at 2 liters nasal cannula.Lung perfusion scan (b)(6) 2020 positive for pulmonary emboli (pe).Lower extremity ultrasound (b)(6) 2020) negative for deep vein thrombosis.Pt started on a heparin drip.Acute pe confirmed (b)(6) 2020 on repeat ct scan.No recent travel.Started on po eliquis.Admitted on (b)(6) 2020.Discharged (b)(6) 2020.Last ecp treatment (#8) prior to this event (b)(6) 2020.Ecp treatment #9 resumed (b)(6) 2020.
 
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Brand Name
CELLEX SYSTEM
Type of Device
SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
Manufacturer (Section D)
THERAKOS, INC. / MALLINCKRODT PHARMACEUTICAL
bedminster NJ
MDR Report Key10991644
MDR Text Key221279510
Report NumberMW5098316
Device Sequence Number1
Product Code LNR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/07/2020
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 No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/10/2020
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; Other;
Patient Age60 YR
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