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

Catalog Number CLXECP

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a bag leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed the treatment bag was leaking from the needle free injection port during the photoactivation phase of the procedure.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 will return the kit and photographs for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction bag 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 l155 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l155 shows no trends.Trends were reviewed for complaint category, bag leak.No trends were detected for this complaint category.At the time of this report, the analysis of the returned kit and photographs is still in process.A final report will be filed when the analysis is complete.(b)(4).(b)(6).

Manufacturer Narrative

The complaint kit, smart card and photographs were provided by the customer for evaluation.Smart card data showed that buffy coat collection phase began after 1489ml of whole blood had been processed.Multiple alarm #48: treatment bag - air detected alarms occurred during photoactivation phase of the treatment, before the treatment was aborted by the operator.Evaluation of the customer provided photographs verified the bag leak as blood is seen leaking from the treatment bag.In addition, the needle-free port is seen with a puncture mark through the port.The treatment bag was the only part of the kit returned for examination.The treatment bag was pressure tested to check for leaks and a leak was verified at the needle-free port.The puncture mark to the needle-free port is consistent with damage that occurs if the operator uses a needle to inject medication into the treatment bag.A material trace of the port and its components used to build lot l155 found no related non-conformances.The device history record (dhr) review did not identify any related non-conformances, deviations, or equipment maintenance events.This kit lot passed all lot release testing.The damage to the needle-free port is consistent with the use of a needle on the needle-free port; however, the customer reported they did not use a needle.The root cause of the bag leak could not be determined based on the available information.No further action is required at this time.The investigation is now complete.(b)(4) 01-feb-2024.

• 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; i.d.a. business park; castlerea roscommon, ; EI
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 17996488
• MDR Text Key: 326394123
• Report Number: 3013428851-2023-00061
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CLXECP
• Device Lot Number: L155
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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