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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 Problem Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction alarm #7: blood leak (centrifuge chamber).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 k127 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot k127 shows no trends.Trends were reviewed for complaint category, alarm #7: blood leak? (centrifuge chamber).No trends were detected for this complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned smart card data is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).P.T.19-jan-2022.
 
Event Description
The customer contacted mallinckrodt to report they received an alarm #7: blood leak? (centrifuge chamber) with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received a red blood cell pump alarm when approximately 657 ml of whole blood was processed.The customer paused the treatment, inspected the tubing, and cleaned the bowl optic sensor.The customer stated while cleaning the bowl optic sensor an alarm #7: blood leak? (centrifuge chamber) was received.The customer did not observe any leaks in the centrifuge chamber.Before resuming the treatment, the customer stated they were unsure if they injected heparin into the saline bag and unsure if the proper amount was injected.As a result, the treatment was aborted and no residual blood within the kit was returned to the patient.The customer stated the patient was in stable condition and will return the next day to receive treatment with a new kit.The customer returned the smart card data for evaluation.
 
Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction alarm #7: blood leak (centrifuge chamber).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 k127 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot k127 shows no trends.Trends were reviewed for complaint category, alarm #7: blood leak? (centrifuge chamber).No trends were detected for this complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned smart card data is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).
 
Event Description
The customer contacted mallinckrodt to report they received an alarm #7: blood leak? (centrifuge chamber) with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received a red blood cell pump alarm when approximately 657 ml of whole blood was processed.The customer paused the treatment, inspected the tubing, and cleaned the bowl optic sensor.The customer stated while cleaning the bowl optic sensor an alarm #7: blood leak? (centrifuge chamber) was received.The customer did not observe any leaks in the centrifuge chamber.Before resuming the treatment, the customer stated they were unsure if they injected heparin into the saline bag and unsure if the proper amount was injected.As a result, the treatment was aborted and no residual blood within the kit was returned to the patient.The customer stated the patient was in stable condition and will return the next day to receive treatment with a new kit.The customer returned the smart card data for evaluation.
 
Manufacturer Narrative
The smart card data was not returned for analysis.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.No further action is required at this time.This investigation is now complete.Comp (b)(4).P.T.02-may-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 Key13295312
MDR Text Key286332110
Report Number3013428851-2022-00006
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 05/02/2022
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 Catalogue NumberCLXECP
Device Lot NumberK127
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2021
Initial Date FDA Received01/19/2022
Supplement Dates Manufacturer Received04/22/2022
Supplement Dates FDA Received05/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2021
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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