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

Catalog Number CLXUSA

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit during an extracorporeal photopheresis (ecp) treatment.The customer reported a drive tube break during the treatment procedure.The customer reported approximately 40ml of whole blood was processed.The customer reported the patient was in stable condition.The customer returned a photograph for investigation.

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 k307a was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot k307a shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.A photograph was provided by the customer for evaluation.The kit and smart card were not returned.Review of the photograph verifies the drive tube is damaged.The drive tube is twisted at the location of the upper drive tube bearing stop.A known cause of a broken drive tube is when the drive tube is not rotating freely.A material trace of the drive tube assembly and its components used to build lot k307a found no related non-conformances.A 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 of the drive tube break could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).N.S.(b)(6) 2022.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; 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: 15429266
• MDR Text Key: 303911213
• Report Number: 3013428851-2022-00070
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)K307(17)230201
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: CLXUSA
• Device Lot Number: K307A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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
• Patient Sex: Female