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

Catalog Number CLXUSA

Device Problems Break (1069); Leak/Splash (1354); Noise, Audible (3273)

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

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube 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 l319 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l319 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak? (centrifuge chamber) and drive tube leak/break.No trends were detected for these complaint categories.Photographs were provided by the customer for evaluation.The complaint kit and smart card were not returned.The provided photographs verify the reported drive tube leak as blood splatter is seen on the centrifuge chamber walls.The upper drive tube bearing is not installed into the drive tube retainer clip.The upper drive tube bearing is seen halfway down the length of the drive tube.If the drive tube bearing is not securely loaded into its retainer clip, the centripetal force would cause the bearing to move to the center of the drive tube and eventually impact the centrifuge chamber wall, resulting in a leak.A material trace of the drive tube assembly and its components used to build lot l319 found no related non-conformances.The requested 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 root cause for the alarm #7: blood leak? (centrifuge chamber) is most likely due to the drive tube leak.The root cause for the drive tube leak is most likely due to the drive tube bearing not being secured into its retainer during installation of the kit by the end user.No manufacturing related defects were identified during this investigation.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported a drive tube break during treatment, after 250ml of whole blood had been processed.The customer reported they heard a loud noise and an alarm #7: blook leak (centrifuge chamber) posted.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 returned photographs for investigation.

• 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 Key: 15892972
• MDR Text Key: 307839213
• Report Number: 3013428851-2022-00083
• Device Sequence Number: 1
• Product Code: LNR
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2022

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 Date: 03/01/2024
• Device Catalogue Number: CLXUSA
• Device Lot Number: L319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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 Age: 25 YR
• Patient Sex: Female