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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 C364 - KIT
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2015
Event Type  malfunction  
Event Description
Customer called to report centrifuge bowl break during treatment procedure.Customer stated the centrifuge bowl is in pieces and the leak detector strip is damaged.Customer stated the patient is stable and they have started the patient on a new procedure on another instrument.The customer stated the leak was contained within the centrifuge.Customer stated there were no alarms during prime and no alarms prior to the bowl break.Customer stated kit will not be returned but she will send pictures.Customer biomed engineer called back to report there is blood leaking from the inside of the instrument.Service order (b)(4) was dispatched.
 
Manufacturer Narrative
A review of lot c364 was performed and there were no nonconformances related to this complaint.This lot met release requirements.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected.A capa was initiated for complaint category, centrifuge bowl leak/break.The assessment is based on information available at the time of the investigation.The customer sent photos and the smart card data for evaluation; this evaluation is still in process.A supplemental report will be filed when this evaluation is complete.Kit unique identifier (udi)#: (b)(4).Meddra codes: lt-device malfunction-(b)(4).Kit was not returned.
 
Manufacturer Narrative
Service order, (b)(4), completed: the service technician removed all of the covers and took apart the door.Blood was cleaned out of the machine the leak detector strip was replaced.The system checkout procedure was completed satisfactorily.Service was performed four days later because the centrifuge bowl holder had a bent tab which was noticed by the customer on monday after returning the instrument to service.Service engineer replaced the bowl holder and performed system checkout procedure and a water treatment.The smartcard and photographs were returned for analysis.The smartcard data indicated that the prime was completed successfully, the leak had occurred and there was a blood leak (centrifuge) alarm, a system error alarm and air detector alarms seen.The photos show that the bowl was broken in pieces and the drive tube was broken just above the lower bearing stop.However, there is not enough information to determine the cause of the break.Further evaluation of the photos determined that the most likely root cause of the bowl and drive tube break was due to the bowl coming out of the platen during the treatment.If the bowl was not locked into the platen by the locking tab, it could have released during the procedure and bent the slot.The device history record (dhr) review did not result in any related nonconformances.(b)(4).Kit was not returned.
 
Event Description
Customer called to report centrifuge bowl break during treatment procedure.Customer stated the centrifuge bowl is in pieces and the leak detector strip is damaged.Customer stated the patient is stable and they have started the patient on a new procedure on another instrument.The customer stated the leak was contained within the centrifuge.Customer stated there were no alarms during prime and no alarms prior to the bowl break.Customer stated kit will not be returned but she will send pictures.Customer biomed engineer called back to report there is blood leaking from the inside of the instrument.Service order (b)(4) was dispatched.
 
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Brand Name
THERAKOS CELLEX PHOTOPHERESIS SYSTEM
Type of Device
CELLEX
Manufacturer (Section D)
THERAKOS, INC.
west chester PA
Manufacturer (Section G)
HARMAC MEDICAL PRODUCTS
2201 baily ave.
buffalo NY 14211
Manufacturer Contact
dianna inguanzo
10 north high street
suite 300
west chester, PA 19380
MDR Report Key4649905
MDR Text Key5613584
Report Number2523595-2015-00080
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 Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Expiration Date12/01/2016
Device Lot NumberC364 - KIT
Other Device ID Number10705030100009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2015
Initial Date FDA Received04/01/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2014
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 Age69 YR
Patient Weight85
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