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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERAKOS, INC THERAKOS CELLEX PHOTOPHERESIS SYSTEM

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THERAKOS, INC THERAKOS CELLEX PHOTOPHERESIS SYSTEM Back to Search Results
Lot Number E305 - KIT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Chills (2191); Patient Problem/Medical Problem (2688)
Event Date 04/26/2016
Event Type  Injury  
Manufacturer Narrative
This system was used for treatment.Kit lot e305 was reviewed.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trends were detected for complaint category cough, weakness, hypotension, chills or "seeing the color purple".Low (narrow) pulse pressure-a pulse pressure is considered abnormally low if it is less than 25% of the systolic value.The most common cause of a low (narrow) pulse pressure is a drop in left ventricular stroke volume.If the pulse pressure is extremely low, i.E.25 mmhg or less, the cause may be low stroke volume, as in congestive heart failure and/or shock.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).
 
Event Description
Customer called to report a patient on cellex instrument 40549 that is not feeling well.Customer reported the male patient started coughing so much that he is out of breath, the patient reported "seeing the color purple", feeling weak, and very cold.Customer stated the patient started coughing when the patient's dialysis catheter was accessed to draw labs prior to starting ecp.Customer has processed 447ml whole blood processed, the patient is alert in the trendelenburg position with his head higher, warm blankets applied, a drink was offered to the patient, in double-needle mode collecting at 30ml/min and returning at 35ml/min (blood pressure: 70/64).Css advised the customer to reduce the return rate to 15ml/min and end the treatment.Customer stated the patient was not coughing as much, catching his breath.Patient stated his vision returned to normal, customer stated his vitals were also returning to normal.Customer stated the patient is an md himself, and she will give the patient some saline before sending the patient home.Patient reported to be stable and alert.
 
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Brand Name
THERAKOS CELLEX PHOTOPHERESIS SYSTEM
Type of Device
CELLEX
Manufacturer (Section D)
THERAKOS, INC
hampton NJ 08827
Manufacturer (Section G)
HARMAC MEDICAL PRODUCTS
2201 baily ave
buffalo NY 14211
Manufacturer Contact
megan vernak
53 frontage road
hampton, NJ 08827
MDR Report Key5660610
MDR Text Key45329011
Report Number2523595-2016-00120
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/26/2016
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 Nurse
Device Expiration Date02/01/2018
Device Lot NumberE305 - KIT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/26/2016
Initial Date FDA Received05/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight57
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