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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

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THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM Back to Search Results
Model Number NOT APPLICABLE
Device Problems Break (1069); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot g350 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g350 shows no trends.Trends were reviewed for complaint category, drive tube leak/break and alarm #7: blood leak? (centrifuge chamber).No trends were detected for either complaint category.The assessment is based on the information available at the time of investigation.No product was returned for investigation.Review of the customer's complaint description determined the reported drive tube leak/break was caused by the user.The customer admitted that they did not secure the drive tube bearing clip, which caused the drive tube to come loose and break.No further investigation is required at this time.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(4).S.D.A.(b)(6) 2018.
 
Event Description
Customer called to report a blood leak in the centrifuge chamber due to the drive tube breaking at the upper bearing.Customer stated that alarm #7: blood leak occured.Customer stated the leak occurred at the very start of the treatment but did not know the exact volume of blood processed.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable and received treatment on another instrument.The customer admitted that she did not secure the bearing clip causing the drive tube to come loose and break.The customer indicated that no product is available for evaluation.
 
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Brand Name
CELLEX PHOTOPHERESIS SYSTEM
Type of Device
CELLEX PHOTOPHERESIS SYSTEM
Manufacturer (Section D)
THERAKOS INC.
bedminster NJ 07921
Manufacturer (Section G)
MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
college business & tech park
cruiserath road
blanchardstown, dublin D15 T X2V
EI   D15 TX2V
Manufacturer Contact
megan vernak
1425 us route 206
bedminster, NJ 07921
MDR Report Key8161863
MDR Text Key131792845
Report Number2523595-2018-00171
Device Sequence Number1
Product Code LNR
UDI-Device Identifier20705030200003
UDI-Public(01)20705030200003(10)G350(17)200701
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
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/13/2018
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 Health Professional
Device Expiration Date07/01/2020
Device Model NumberNOT APPLICABLE
Device Catalogue NumberCLXUSA
Device Lot NumberG350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2018
Initial Date FDA Received12/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2018
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 Weight98
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