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

Catalog Number CLXUSA

Device Problems Fluid/Blood Leak (1250); Pressure Problem (3012)

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

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pto leak.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 j369 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j369 shows no trends.Trends were reviewed for complaint categories, pto leak and alarm #18: system pressure.No trends were detected for these complaint categories.A photograph was provided by the customer for evaluation.The complaint kit was not returned.Review of the customer provided photograph verifies the pump tubing organizer (pto) leak as blood is seen leaking from the y-connector inside the pto.The leak appears to be coming from the bond where the y-connector joins the plasma line to the treatment bag and return bag inlet lines.A material trace of the components used to build kit lot j369 found one related non-conformance.The related non-conformance was associated with y-connector lot # 1000835 which involved a leak identified at the same location during lot release testing.A review of all pto leaks documented in mallinckrodt's electronic complaint database from january 2020 to present did not identify any similar occurrences associated with y-connector lot # 1000835.There were no other pto leaks observed for kit lot j369.A device history record review for kit lot j369 did not identify any related non-conformances and this kit lot had passed all lot release testing.The reported alarm #18: system pressure alarm was most likely caused by the leak at the y-connector.The root cause of the leak was most likely due to a weak solvent bond or due to a sink in the y-connector bond socket; however, a definitive root cause could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).P.T.(b)(6) 2021.

Event Description

The customer contacted mallinckrodt to report they experienced a pump tubing organizer (pto) leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #18: system pressure alarm after approximately 500 ml of whole blood had been processed.The customer observed a blood leak in the pto.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The patient started a new ecp treatment with a new kit.The customer returned a photograph 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: 11790730
• MDR Text Key: 252195534
• Report Number: 2523595-2021-00041
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J369(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: 05/07/2021

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: 09/01/2022
• Device Catalogue Number: CLXUSA
• Device Lot Number: J369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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