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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); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2020
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 h373 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h373 shows no trends.Trends were reviewed for complaint categories, alarm #17: return pressure, alarm #9: blood pump error, alarm #7: blood leak? (centrifuge chamber) and centrifuge bowl leak/break.No trends were detected for each complaint category.The customer returned the ecp treatment's smart card for evaluation.Review of the data recorded on the smart card verified the reported alarms by the customer.The data shows an alarm #17: return pressure alarm occurred at the beginning of the procedure, followed by an alarm #9: blood pump error alarm after 22 ml of whole blood had been processed.The treatment proceeded through the purging air phase and an alarm #7: blood leak? (centrifuge chamber) alarm occurred at 245 ml whole blood processed.The alarm #7 occurs when fluid is detected within the centrifuge chamber by the leak sensor.The alarm #7 most likely occurred due to the reported centrifuge bowl break; however, a root cause for the centrifuge bowl break 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 #17: return pressure and alarm #9: blood pump error alarm early in the procedure.The customer stated they heard the sound of a clip coming loose in the centrifuge chamber before the centrifuge bowl broke.The customer received an alarm #7: blood leak? (centrifuge chamber) alarm and noticed the centrifuge bowl had detached from the bowl holder.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was in stable condition.The customer returned the kit's smart card 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 Key10088371
MDR Text Key198759817
Report Number2523595-2020-00061
Device Sequence Number1
Product Code LNR
UDI-Device Identifier20705030200003
UDI-Public(01)20705030200003(10)H373(17)211101
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 05/26/2020
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 Date11/01/2021
Device Model NumberNOT APPLICABLE
Device Catalogue NumberCLXUSA
Device Lot NumberH373
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/04/2020
Initial Date FDA Received05/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2019
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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