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

Catalog Number CLXECP

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/06/2023

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 l155 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l155 shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.At the time of this report, the analysis of the returned smart card and photographs is still in process.A final report will be filed when the analysis is complete.(b)(4).N.S.03-oct-2023.

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 after approximately 100 ml of whole blood had been processed.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The customer reported the patient was in stable condition.The customer will return the smart card and photographs for investigation.

Manufacturer Narrative

The smart card and photographs were provided by the customer for evaluation.The complaint kit was not returned.Smart card data showed alarm #7: blood leak? (centrifuge chamber) alarms occurred after 97 ml of whole blood was processed.A visual inspection of the customer supplied photographs showed that the centrifuge bowl had dislodged out of the bowl holder and impacted the inside the centrifuge chamber during the treatment.The drive tube was broken apart from the centrifuge bowl and there is blood splatter on the walls of the centrifuge chamber.A known cause for the centrifuge bowl to dislodge out of the bowl holder is due to the centrifuge bowl not properly locked into the bowl holder during installation.A material trace of the bowl assembly and its components used to build lot l143 found no related non-conformances.The device history record (dhr) review did not identify any related non-conformances, deviations, or equipment maintenance events.This lot passed all lot release testing.The most likely root cause of the bowl break is due to improper installation of the centrifuge bowl into the bowl holder.No further action is required at this time.This investigation is now complete.(b)(4).N.S.(b)(6) 2024/.

• 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): HARMAC MEDICAL PRODUCTS; i.d.a. business park; cruiserath road; castlerea roscommon, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 17862859
• MDR Text Key: 324826732
• Report Number: 3013428851-2023-00057
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CLXECP
• Device Lot Number: L143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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
• Patient Sex: Female