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

Catalog Number CELLEX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anemia (1706)

Event Date 12/20/2020

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the blood transfusion that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.A device service history review could not be performed as an instrument serial number was not provided.Trends were reviewed for complaint categories clot observed, alarm #17: return pressure, alarm #16: collect pressure, and low hemoglobin.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: anemia.Comp (b)(4).(b)(6).

Event Description

A mallinckrodt clinical specialist reported that an extracorporeal photopheresis (ecp) patient experienced low hemoglobin following a treatment procedure.The clinical specialist stated that a new operator was running an ecp treatment procedure with acda as the anticoagulant at a ratio of 10:1.The clinical specialist reported that the operator continued with the treatment procedure despite having many alarm #16: collect pressure and alarm #17 return pressure alarms throughout the treatment.The clinical specialist stated that the buffy coat was collected after 1700ml of whole blood had been processed.The clinical specialist reported that prior to photoactivation, the operator noticed clots in the centrifuge bowl, treatment bag, and return bag.The clinical specialist stated that the operator then aborted the treatment without blood return to the patient.The clinical specialist reported that the hospital's assistant nurse manager believed that the operator may have accidentally swapped the kit's lines for the saline and anticoagulant bags during the kit set up.However, the clinical specialist reported that the assistant nurse manager was unable to confirm that this was what happened.The clinical specialist stated that the patient's hemoglobin had dropped from 9g/dl pretreatment to 6g/dl post treatment thus the patient was given a blood transfusion.The clinical specialist reported that the patient was now stable and no further ill effects were noted.The clinical specialist stated that the patient had successfully completed six prior ecp treatments procedures without any issues.In addition, the clinical specialist reported that the patient had successfully completed multiple ecp treatments procedures after this event without any further issues.The clinical specialist reported that the assistant nurse manager has arranged for further training.The clinical specialist stated that she had requested the instrument serial number from the assistant nurse manager; however, the assistant nurse manager was not willing to look for it.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; blanchardstown, dublin ; EI
• 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: 11285233
• MDR Text Key: 230458303
• Report Number: 2523595-2021-00015
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention