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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED CELLEX PHOTOPHERESIS SYSTEM; CELLEX PHOTOPHERESIS SYSTEM, PRODUCT CODE: LNR

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MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED CELLEX PHOTOPHERESIS SYSTEM; CELLEX PHOTOPHERESIS SYSTEM, PRODUCT CODE: LNR Back to Search Results
Catalog Number CLXUSA
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
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 j372 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j372 shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.Photographs and the smart card data were provided by the customer for evaluation.The complaint kit was not returned for investigation.A review of the smart card data showed a blood leak (centrifuge) alarm occurred after 246ml of whole blood had been processed.Review of the provided photographs verify the centrifuge bowl broke as blood splatter is visible on the centrifuge chamber walls, and pieces of the centrifuge bowl are located at the bottom of the centrifuge chamber.Further review of the photographs show the base of the centrifuge bowl is still contained within the bowl holder, indicating the outer bowl had separated from the bowl base.There is a piece of the outer centrifuge bowl still attached to the bowl base, indicating that the break occurred in the outer bowl material and not at the weld between the outer bowl and bowl cover.A material trace of the bowl assembly and its components used to build lot j372 found no related non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.This kit lot had passed all lot release testing.The root cause of the centrifuge bowl break was most likely due to a separation of the outer bowl and bowl base; however, the cause of the separation 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 during the purging air phase of the procedure the centrifuge bowl broke.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 photographs and smart card data for investigation.
 
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Brand Name
CELLEX PHOTOPHERESIS SYSTEM
Type of Device
CELLEX PHOTOPHERESIS SYSTEM, PRODUCT CODE: LNR
Manufacturer (Section D)
MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
blanchardstown, dublin, D15 T X2V
EI  D15 TX2V
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
shelbourne building
53 frontage rd suite 300
hampton, NJ 08827
MDR Report Key12318163
MDR Text Key268034901
Report Number2523595-2021-00068
Device Sequence Number1
Product Code LNR
UDI-Device Identifier20705030200003
UDI-Public(01)20705030200003(10)J372(17)220901
Combination Product (y/n)Y
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 08/13/2021
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 Date09/01/2022
Device Catalogue NumberCLXUSA
Device Lot NumberJ372
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/14/2021
Initial Date FDA Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2020
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 Age67 YR
Patient Weight69
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