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 04/21/2021

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 j370 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j370 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.The complaint kit and a photograph were returned for investigation.The smart card was not returned; therefore, the reported alarm #7: blood leak? (centrifuge chamber) could not be verified.The customer provided photograph shows the lower drive tube retainer clip with dried blood on the clip.Inspection of the received kit confirmed the drive leak as dried blood was found on the drive tube near the lower drive tube bearing stop.The drive tube of the received kit had wear marks around the circumference of the lower drive tube bearing stop.The drive tube was installed on a test instrument and the worn section of the drive tube lined up with the edge of the drive tube retainer clip.The evidence to the drive tube is consistent with a misload of the lower drive tube bearing into the retainer clip causing the drive tube to contact the bearing retainer and leak.The root cause for the drive tube leak was most likely caused by not securing the drive tube bearing into the retainer clip during installation of the drive tube 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).(b)(6) 2021.

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 received an alarm #7: blood leak? (centrifuge chamber) alarm at approximately 1450 ml of whole blood processed.The customer opened the centrifuge chamber door and observed a blood leak.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.The customer returned a photograph and the kit 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: 11828432
• MDR Text Key: 268099576
• Report Number: 2523595-2021-00050
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J370(17)220901
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: CLXUSA
• Device Lot Number: J370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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