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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED CELLEX PHOTOPHERESIS SYSTEM

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MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED CELLEX PHOTOPHERESIS SYSTEM Back to Search Results
Catalog Number CLXECP
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
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 the centrifuge bowl broke during the procedure, after 125ml of whole blood had been processed.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 for investigation.
 
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 k154 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k154 shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.The assessment is based on the information available at the time of investigation.Photographs were provided by the customer for evaluation.The complaint kit was not returned for investigation.Review of the provided photographs verify the centrifuge bowl broke as blood splatter is visible on the centrifuge chamber walls.The centrifuge bowl is no longer secured in the bowl holder.A known cause for the centrifuge bowl to dislodge from the bowl holder is when the centrifuge bowl is not properly secured in the bowl holder during installation of the kit.A material trace of the bowl assembly and its components used to build lot k154 found no related non-conformances.A device history record review did not identify any related nonconformances, deviations, or equipment maintenance events.This kit lot had passed all lot release testing.The root cause of the centrifuge bowl break was most likely due to the centrifuge bowl not being secured into the bowl holder during installation by the kit by the end user.No further action is required at this time.This investigation is now complete.(b)(4).H.M.(b)(6) 2022.
 
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Brand Name
CELLEX PHOTOPHERESIS SYSTEM
Type of Device
CELLEX PHOTOPHERESIS SYSTEM
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 Key14790510
MDR Text Key301824370
Report Number3013428851-2022-00051
Device Sequence Number1
Product Code LNR
Combination Product (y/n)Y
Reporter Country CodeGM
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 06/23/2022
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 Date10/01/2023
Device Catalogue NumberCLXECP
Device Lot NumberK154
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/09/2022
Initial Date FDA Received06/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2021
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 SexFemale
Patient Weight65 KG
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