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

Catalog Number CLXUSA

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction clot observed 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 m321 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot m321 shows no trends.Trends were reviewed for complaint categories, alarm #17: return 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 smart card is still in progress.A supplemental report will be filed when the analysis is complete.Comp (b)(4) ns (b)(6) 2023.

Event Description

The customer contacted mallinckrodt to report blood clotting in the return line with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #17: return pressure alarm during the procedure.The customer inspected the kit and observed blood clots in the return line after 1500 mls of whole blood was processed.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.The customer will return the smart card for investigation.

Manufacturer Narrative

An investigation was performed based on the returned smart card.The kit was not returned for evaluation.Review of the smart card data verified the occurrence of multiple alarm #17: return pressure alarms during blood collection after 21 ml of whole blood had been processed.In addition, multiple alarm #52: collect line air detected alarms were received.The treatment proceeded to buffy coat collection when additional return pressure alarms occurred.After the buffy coat collection phase of the procedure completed, several more return pressure warnings occurred before the treatment was aborted by the operator.The occurrence of the return pressure alarms is consistent with flow restrictions such as blood clotting within the kit.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 judgement to establish the optimal heparin dosage for each patient." the cause of the alarm #17: return pressure alarms was most likely due to the clotting in the kit.The root cause for the blood clotting could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4) 15-jan-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, INC.; 2201 bailey ave.; buffalo; NY 14211
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 18062127
• MDR Text Key: 327270128
• Report Number: 3013428851-2023-00071
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)M321(17)250401
• 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,Followup
• Report Date: 01/15/2024

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: CLXUSA
• Device Lot Number: M321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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