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

Catalog Number CLXECP

Device Problems Coagulation in Device or Device Ingredient (1096); Use of Device Problem (1670)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A kit lot number was not provided; therefore, a batch record review could not be performed.Trends were reviewed for complaint categories, alarm #17: return pressure, clot observed, and treatment error.No trends were detected for these complaint categories.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.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." in addition, section 4-27 on installing the therakos cellex photopheresis procedural kit states "1.Add x units of heparin to a 500 ml bag of 0.9% normal saline and label the bag per your institution's labeling procedures." the customer stated they inadvertently did not add heparin to the saline bag during kit installation.The cause of the alarm #17: return pressure alarm was most likely due to the clotting in the return line.The root cause of the clots observed was most likely due to the operator error during kit installation.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced clots observed 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 when approximately 1178 ml of whole blood had been processed.The customer reported they removed the return line from the patient access line and noticed a clotting in the return line.The customer stated they forgot to add heparin into the saline bag during installation of the kit.The nurse added heparin at the end of the kit prime phase.The ecp treatment was aborted and residual blood within the kit was manually reinfused from the return bag to the patient.The customer reported the patient was in stable condition and would begin a new ecp treatment with a new kit.The customer did not return product 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: 15519778
• MDR Text Key: 306414718
• Report Number: 3013428851-2022-00075
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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
• Report Date: 09/30/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 35 KG