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

Catalog Number CLXUSA

Device Problem Output Problem (3005)

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

Event Date 08/25/2021

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 k313 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k313 shows no trends.Trends were reviewed for complaint categories, alarm #18: system pressure, clot observed and alarm #17: return pressure.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 and photographs is still in progress.A supplemental report will be filed when the analysis is 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 multiple alarm #18: system pressure and alarm #17: return pressure alarms during the procedure.The customer observed blood clotting throughout the kit, and in the return line.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 returned photographs and the smart card data for evaluation.

Manufacturer Narrative

Photographs and the smart card data were returned for evaluation.The complaint kit was not returned.The returned photographs verify blood clotting in the return bag, treatment bag and centrifuge bowl as reported by the customer.An additional photograph verifies blood solids in the collect line.The reported clotting in return line could not be verified based on the photographs.A review of the data recorded on the smart card shows that prime was completed and blood collection began in single needle mode.The treatment proceeded until 115 ml of whole blood was processed and an alarm #18: system pressure alarm occurred.Multiple return pressure and collect pressure warnings occurred afterwards, and the treatment was later aborted by the operator.The pressure warnings recorded on the smart card are consistent with flow restrictions such as clotting.Section 2-9 of the cellex operators manual (1470493 rev06) 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 clinician 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 could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).P.T.(b)(6) 2021.

• 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: 12515362
• MDR Text Key: 273995974
• Report Number: 2523595-2021-00078
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)K313(17)230301
• 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: 11/16/2021

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 Expiration Date: 03/01/2023
• Device Catalogue Number: CLXUSA
• Device Lot Number: K313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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