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

Catalog Number CLXUSA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/20/2024

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 m358 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot m358 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.The kit and smart card were not returned.Evaluation of the customer supplied photographs verified that the drive tube broke as blood splatter is visible on the centrifuge chamber walls.The drive tube retainer clip shown in the customer photographs appears to be damaged.A known cause of the drive tube bearing slipping out of the drive tube retainer is a misload of the drive tube bearing by the end user.The drive tube bearing may have impacted the leak detector strip and centrifuge wall due to centripetal force, the bearing would move to the center of the drive tube (between the upper and lower bearing stops).The weight of the bearing would allow the drive tube to extend, and the bearing would impact the wall causing damage to the leak strip and upper bearing shields.A material trace of the drive tube assembly and its components used to build lot m358 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 drive tube leak is due to the lower drive tube bearing not being secured into the bearing retainer during installation of the kit by the end user.No further action is required at this time.This investigation is now complete.(b)(4).N.S.(b)(6) 2024.

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 they observed a drive tube break during the procedure after 700ml of whole blood was processed.The customer aborted the ecp treatment and no residual blood within the kit was returned to the patient.The customer reported the patient was in stable condition.The kit return was requested; however, the customer discarded the kit.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): HARMAC MEDICAL PRODUCTS, INC.; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 19052414
• MDR Text Key: 340452406
• Report Number: 3013428851-2024-00025
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)M358(17)250801
• 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: 04/05/2024

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 Number: CLXUSA
• Device Lot Number: M358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2023
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 83 KG