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

Catalog Number CLXECP

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is being reported out of an abundance of caution as an mdr due to the reportable malfunction clot observed in the return line.The customer could not confirm if it was blood clotting in the return line.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 l247 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l247 shows no trends.Trends were reviewed for complaint categories, alarm #16: collect pressure and clot observed.No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned photographs and smart card is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4), p.T.10-jul-2023.

Event Description

The customer contacted mallinckrodt to report possible blood clotting in the return line with their cellex photopheresis kit during an extracorporeal photopheresis (ecp) treatment.The customer reported they received multiple alarm #16: collect pressure alarms during the procedure.The customer reported approximately 1343 ml of whole blood was processed when they observed "strange" blood in the return line.The customer stated they could not confirm if it was blood clotting.The ecp treatment was aborted and residual blood within the kit was not returned to the patient.The customer reported the patient was in stable condition and a new ecp treatment was planned for the following day.The kit was requested for return; however, the customer discarded the kit.The customer will return the smart card and photographs for evaluation.

Manufacturer Narrative

Photographs were provided by the customer for evaluation.The complaint kit and smart card were not returned.Review of the customer provided photographs did not verify if blood clots were present in the return line of the cellex photopheresis kit.The provided photographs show the return tubing line and collect tubing line with blood present in both tubing's.A material trace of the tubing used to manufacture kit lot l247 did not find any non-conformances.A device history record review did not result in any related non-conformances.This kit lot passed all lot release testing.Section 2-9 of the cellex operators manual (1470493 rev 6) for use with software 5.4 on anticoagulant states "caution: individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment.The physician should review the patient's medical condition, medications and platelet count at the time of treatment and use clinical judgment to establish the optimal heparin dosage for each patient." the customer report of possible blood clots in the return line was not verified based on the available information.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) 2023.

• 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: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 17293456
• MDR Text Key: 318961116
• Report Number: 3013428851-2023-00038
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/02/2023

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: CLXECP
• Device Lot Number: L247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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
• Patient Sex: Male
• Patient Weight: 50 KG