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

Catalog Number CLXECP

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/05/2022

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: k211 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot: k211 shows no trends.Trends were reviewed for complaint categories, alarm #: 17: return pressure and clot observed.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.The customer stated they added calcium to the collect line instead of the return line in error.The customer stated the calcium likely caused the anticoagulant to neutralize and was the cause of the blood clotting.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 root cause for the clotting observed was most likely due to the operator inadvertently adding calcium to the collect line instead of the return line.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6) 2022.

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 and then they noticed blood clots in the return line, return bag and treatment bag.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 reported they inadvertently used calcium in the collect line rather than the return line which caused the anticoagulant to neutralize and likely resulted in the blood clotting.The customer did not return the 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: 15126003
• MDR Text Key: 304302638
• Report Number: 3013428851-2022-00055
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: TC
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: CLXECP
• Device Lot Number: K211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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