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

Model Number	CELLEXUSA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hemolysis (1886); Nausea (1970); Pneumonia (2011); Hematuria (2558); Paresthesia (4421)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that an extracorporeal photopheresis (ecp) patient experienced paresthesia, dyspnea, nausea, hemolysis, hematuria, and pneumonia during an ecp treatment procedure.The customer stated that this particular patient was not a new patient and has undergone more than 200 ecp treatment procedures to date.The customer reported that the patient was a little grumpy prior to their ecp treatment procedure, but this was not unusual.The customer stated that the patient did not seem 100% normal prior to their ecp treatment procedure but seemed "fine" the customer reported that they began the patient's ecp treatment procedure with acda as the anticoagulant.The customer stated that there was an alarm #45: red blood cell pump alarm during the patient's ecp treatment procedure which they were able to resolve and continue with the treatment.The customer reported that the patient's ecp treatment procedure eventually moved into the photoactivation phase.The customer reported that the photoactivation time for the treated cells was 43 minutes and that the cells seemed darker than usual.The customer reported that mid-way through the patient's ecp treatment procedure the patient began to experience a tingling feeling, shortness of breath and nausea.The customer reported that they then placed the patient on oxygen and aborted their ecp treatment procedure due to the patient feeling unwell and short of breath.The customer stated that blood labs taken after the patient's aborted ecp treatment procedure indicated hemolysis.The customer reported that there were no signs of hemolysis in either the celelx kit or centrifuge bowl during the patient's ecp treatment procedure.The customer also reported that the patient complained of blood in their urine after he went to the restroom.The customer stated that out of precaution the patient was admitted to the hospital.The customer reported that they did not know what medical interventions were provided to the patient when he was admitted, and that the patient was still in the hospital.The customer stated that the patient was found to have pneumonia.The customer reported that they did not know the root cause of the patient's symptoms, but they did feel that the patient's ecp treatment procedure could not be ruled out as a contributing factor.The customer reported that they have removed the instrument from use as they were not sure if the patient's hemolysis was caused by a mechanical issue or by patient related issues.The customer has requested service for the instrument.The instrument's smart card was returned for investigation.
Additional 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 oxygen 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 was performed.The instrument has been located at the customer's site since (b)(6) 2021.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6) 2021 during 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.The instrument was examined by a therakos service technician on (b)(6) 2022.During the examination, the service technician found binding rollers on the anticoagulant pump head and replaced the anticoagulant pump head.The service technician then successfully performed the system checkout procedure indicating that the instrument had passed all tests, met all specifications, and was operational.The instrument's bowl optics, hematocrit sensor, and pump calibrations were all found to be well within specifications.There were no other issues found with this instrument.The smart card data was reviewed.The smart card data indicated that prime was completed without incident.The acda anticoagulant (ac) ratio was changed to 8:1 and collection was started 5.5 hours later in single needle mode.Alarm #16: collect pressure warnings then occurred followed by an alarm #45: red blood cell pump alarm after 811 ml of whole blood processed.The bowl optic sensor threshold was reduced to 120.A second alarm #45: red blood cell pump alarm occurred after 930 ml of whole blood processed.The target for whole blood processed was reduced to 1000 ml and the ac ratio was changed to 14:1.Buffy coat collection began and alarm #16: collect pressure warnings occurred.An alarm #10: buffy volume exceeded alarm occurred after 181 ml of buffy coat had been collected.A second alarm #10: buffy volume exceeded alarm occurred after 206 ml of buffy coat had been collected.The bowl optic sensor threshold was reduced to 70.A third alarm #10: buffy volume exceeded alarm occurred and the bowl optic sensor threshold was reduced to 25.The operator pressed the end buffy button after 272 ml of buffy volume had been collected.The photoactivation phase began with a calculated time of 42 minutes, 45 seconds; however, the operator pressed the end treatment button 1.5 minutes later.Photoativation was not completed.The operator then pressed the abort treatment button.Review of smart card data did not find any indications of any issue with the kit or with the performance of the instrument.The root cause for the patient's paresthesia, dyspnea, nausea, hemolysis, hematuria, and pneumonia could not be determined based on the available information.Trends were reviewed for complaint categories, paresthesia, dyspnea, nausea, hemolysis, hematuria, and pneumonia.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: paresthesia, dyspnea, nausea, hemolysis, hematuria, and pneumonia.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Common Device Name: 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: 13596240
• Report Number: 3013428851-2022-00022
• Device Sequence Number: 12226626
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)210125
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: CELLEXUSA
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male