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

Catalog Number CLXUSA

Device Problems Break (1069); Fluid/Blood Leak (1250); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

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 k314 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k314 shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break and alarm #18: system pressure.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 returned photograph 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 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 #18: system pressure at the time of the bowl break occurred.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 and the patient returned the next day to receive their ecp treatment.The customer returned photographs.

Manufacturer Narrative

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 and an alarm #18: system pressure alarm occurred after 223ml of whole blood had been processed.Review of the provided photograph verifies 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 on the centrifuge chamber.Further review of the photograph shows the base of the bowl is still contained within the bowl holder, indicating that the outer bowl had separated from the bowl base.There are pieces 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: k314 found no related non-conformances.A device history record review did not identify any related non-conformances, 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 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).(b)(6) on (b)(6) 2021.

• 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 ; 9082351030
• MDR Report Key: 12635656
• MDR Text Key: 279178031
• Report Number: 2523595-2021-00085
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)K314(17)230301
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

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 Date: 03/01/2023
• Device Catalogue Number: CLXUSA
• Device Lot Number: K314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1