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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
Catalog Number CLXECP
Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2020
Event Type  malfunction  
Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl 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 h168 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h168 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak? (centrifuge chamber), centrifuge bowl leak/break.No trends were detected for each complaint category.The customer returned photographs for evaluation.The supplied photographs verify the centrifuge bowl leaked as blood splatter is seen on the centrifuge chamber walls.The bowl appears to be intact and still locked into the bowl holder of the cellex instrument.The photographs show a crack running across the side of the centrifuge bowl.A material trace of the bowl assembly and its components used to build lot h168 found no related non-conformances.A device history record review of kit lot h168 did not identify any related non-conformances and this kit lot had passed all lot release testing.The cause of the centrifuge bowl leak was most likely due to the crack in the outer centrifuge bowl.The root cause of the crack in the centrifuge bowl could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).
 
Event Description
The customer contacted mallinckrodt to report they experienced a centrifuge bowl leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #7: blood leak? (centrifuge chamber) and inspected the centrifuge chamber where a leak was observed.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported approximately 90 ml of whole blood was processed at the time the leak occurred.The customer reported the patient was in stable condition.The customer returned photographs for investigation.
 
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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 Key10323818
MDR Text Key209846381
Report Number2523595-2020-00087
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
P860003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/24/2020
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 Date12/01/2021
Device Catalogue NumberCLXECP
Device Lot NumberH168
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/25/2020
Initial Date FDA Received07/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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