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

Model Number CELLEXUSA

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

Patient Problems Chest Pain (1776); Hemolysis (1886); Hematuria (2558)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and also due to the medical intervention of the blood transfusions that were provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument malfunction and no instrument issue was alleged by the customer.No service was requested by the customer for this adverse event.A device service history review was performed.The instrument has been located at the customer's site since (b)(6) 2022.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6) 2022 (installation).During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Two photographs were provided by the customer for investigation.The first photograph shows the centrifuge bowl during the buffy coat collection phase of the ecp treatment.Review of the photograph determined the centrifuge bowl exhibited visual evidence of hemolysis due to the dark reddish plasma and buffy coat.The instrument's bowl optic sensor was reported to have read a value of 150 because of the darker hemolyzed plasma and buffy coat.As a result, the instrument likely interpreted the dark hemolyzed plasma as red blood cells (rbcs) and continued to operate as if the buffy coat / rbc interface had been reached.The customer reported that they only observed rbcs within centrifuge bowl; however, the photograph depicts a buffy coat / rbc layer.The plasma and buffy coat was dark and likely contributed to the customer's inability to locate the interface at eye level.The second photograph shows the contents in the return bag of the cellex kit.Review of the photograph determined the return bag also exhibited visual evidence of hemolysis due to the dark reddish plasma and buffy coat.The root cause for the hemolysis could not be determined based on the available information section 5-4 of the cellex operator's manual states "throughout the treatment you should visually monitor the instrument to confirm whole blood separation; the correct position for the plasma/red blood cell interface; unusual conditions such as hemolysis, high bilirubin and/or lipids; and unexpected fluid leaks.If hemolysis or unexpected air is observed during a photopheresis treatment, the therapy must be aborted and blood should not be returned to the patient." trends were reviewed for complaint categories, bowl optic sensor, chest pain, hemolysis, and hematuria.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: chest pain, hematuria, and hemolysis.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced chest pain, hematuria, and hemolysis during an ecp treatment procedure.The customer stated that the patient was being treated for kidney transplant rejection.The customer reported that an alarm #17: return pressure alarm occurred at 1178ml of whole blood processed.The customer stated that the patient's ecp treatment procedure was in double needle mode.The customer reported that the instrument's display stated that the instrument's return pressure was above the maximum limit and the customer stated that it was impossible to reset this alarm.The customer stated that they removed the cellex kit's return line from the patient's access and discovered a clot at the patient's access.The customer reported that a saline bolus was performed, and a couple of clots came out from the return line.The customer then admitted that they had forgotten to add heparin into the saline bag during the installation of the cellex kit thus the kit had been primed only with saline.The customer reported that they had added the heparin (12500u/500ml of saline) at the end of the kit prime and before the patient had been connected to the instrument.The customer stated that they then decided to swap the patient's ecp treatment procedure to single needle mode in order to rinse the patient's return access.The customer reported that they then resumed the patient's ecp treatment procedure in single needle mode with a collect flow rate of 20ml/min and a return flow rate of 25ml/min.The customer stated that they finally decided to stop the patient's ecp treatment procedure at 1300ml of whole blood processed as no plasma/red blood cell interface appeared in the kit's centrifuge bowl.The customer reported that the kit's centrifuge bowl was filled with red blood cells only.The customer stated that the kit's centrifuge bowl had emptied without any problems; however, during the return phase, an alarm #53: return line air detected alarm occurred.The customer reported that they then removed the kit's return line from the instrument's air detector, and while they did not see any air bubbles there was another clot in the kit's return line.The customer stated that they then decided to abort the patient's ecp treatment procedure and to manually reinfuse the 300ml of red blood cells in the kit's return bag back to the patient due to the patient's hematocrit of 27%.The customer reported that patient's physician decided to start a new ecp treatment with a new kit for this patient.The customer stated that during the patient's second ecp treatment procedure of the day, they had to pause the patient's ecp treatment procedure at 450ml of whole blood processed.The customer reported that even though the kit's bowl optic sensor was reading at 150, a plasma/red blood cell interface still had not formed.The customer reported that the patient's second ecp treatment procedure was in double needle mode, with a collect flow rate of 30ml/min, a return flow rate of 35ml/min, and an anticoagulant (heparin) ratio of 10:1.The customer stated that they began to suspect that hemolysis may have occurred due to the appearance of the patient's blood in the kit's return bag.The customer reported that after having paused the patient's second ecp treatment procedure for a while with no plasma/red blood cell interface appearing in the kit's centrifuge bowl they decided to end the patient's second ecp treatment procedure.The customer stated that as they were unsure if hemolysis had occurred and there was no physician available at the time, they decided to return the patient's blood due to the patient's hematocrit of 27%.The customer reported that the patient was stable after both ecp treatment procedures, and the patient had left the hospital.However, the customer stated that while in the taxi going home from the hospital, the patient began to experience chest pain and returned to the hospital.The customer reported that the patient was admitted to the hospital due to their chest pain and hematuria.The customer stated that it was confirmed that hemolyzed blood was returned to the patient through a blood test that was carried out after the end of the patient's second ecp treatment procedure and also by the patient's symptoms of hematuria and chest pain.The customer reported that the patient received two packed red blood cell transfusions while in the hospital.The customer stated that the first blood transfusion (265ml) occurred on (b)(6) 2022 and the second blood transfusion (304 ml) occurred on (b)(6) 2022.The customer reported that no other medical intervention or treatment was provided to the patient.The customer stated that the patient was discharged from the hospital on (b)(6) 2022 at the end of the day.The customer reported that the patient's ecp treatments will now be discontinued due to this incident and also due to a lack of results regarding the patient's kidney transplant rejection.The customer stated that the patient will start dialysis again.The customer reported that their physicians do not believe that patient's chest pain and hematuria were related to the cellex instrument but instead to the patient's ecp treatment procedures and to the hemolysis that occurred due to the patient's ecp treatment procedures.The customer returned photos 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: 15499286
• MDR Text Key: 300726754
• Report Number: 3013428851-2022-00077
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)211214
• 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: 09/27/2022

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 Model Number: CELLEXUSA
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 35 KG