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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 07/15/2022
Event Type  malfunction  
Event Description
The customer contacted mallinckrodt to report they experienced a photoactivation module leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #8: blood leak? (photoactivation chamber) alarm.The customer noticed the photoactivation plate broke during the photoactivation phase of the procedure after 1540 ml of whole blood have 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 photoactivation module leak.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 k254 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k254 shows no trends.Trends were reviewed for complaint categories, photoactivation module leak, alarm #8: blood leak (photoactivation chamber), and alarm #7: blood leak (centrifuge chamber).No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).
 
Manufacturer Narrative
A photograph was provided by the customer for evaluation.The complaint kit and smart card were not returned.Review of the photograph verifies the photoactivation module leak as blood is seen leaking through a crack in the photoactivation module.A material trace of the illumination plates used to build lot k254 did not find any non-conformances.A device history record (dhr) review did not result in any related non-conformances.This lot was passed all lot release testing.All photoactivation plates are inspected prior to packaging; therefore, it is unlikely the crack to the photoactivation module was present at the time of manufacture.The cause of the alarm #8: blood leak? (photoactivation chamber) was most likely due to the leak in the photoactivation chamber.The root cause of the photoactivation module leak was due to the cracks in the plate; however, the cause of the crack could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4) h.M.15 sep 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 Key15169513
MDR Text Key305266964
Report Number3013428851-2022-00057
Device Sequence Number1
Product Code LNR
Combination Product (y/n)Y
Reporter Country CodeIT
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,Followup
Report Date 09/15/2022
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 Date11/01/2023
Device Catalogue NumberCLXECP
Device Lot NumberK254
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/15/2022
Initial Date FDA Received08/04/2022
Supplement Dates Manufacturer Received08/17/2022
Supplement Dates FDA Received09/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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