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

Catalog Number	CELLEX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Low Oxygen Saturation (2477); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that an extracorporeal photopheresis (ecp) patient experienced dyspnea, oxygen desaturation, tachypnea, tachycardia, and hypertension following their ecp treatment procedure.The customer stated that the patient was undergoing ecp therapy for the treatment of chronic multiple system gvhd of the joints, mouth and liver.The customer reported that the patient underwent their first ecp treatment procedure on (b)(6) 2024.The customer stated that the patient was also being treated for pre-existing hypertension and the patient was given an anti-hypertensive, amlodipine 2.5 mg, at home prior to their ecp treatment procedure.The customer reported that they did not know how far in advance of the patient's ecp treatment procedure the anti-hypertensive was given to the patient.The customer stated that the patient's pretreatment vital signs were blood pressure 130/98, respiratory rate 24, heart rate126, and temperature 36.6.The customer reported that 1500mls of whole blood was processed in double needle mode with a collect rate of 30ml/min and a return rate of 35ml/min during the patient's ecp treatment procedure.The customer stated that the patient's ecp treatment procedure was successfully completed and the patient's fluid balance at the end of their ecp treatment procedure was +403ml.The customer reported that the patient began to complain of shortness of breath after the completion of their ecp treatment procedure.The customer stated that the patient's oxygen saturation then decreased to 88% and 2 liters/minute of oxygen was administered to the patient through a 2-liter nasal cannula (2l/nc).The customer reported that a code blue was called, and the patient was admitted to the hospital for tachypnea, tachycardia, respiratory distress, and hypertension.The customer stated that the patient's vital signs at the time of event were heart rate 124, blood pressure 136/103, respiratory rate 24, and oxygen saturation 93% on 2l/nc.The customer reported that while in the hospital the patient's blood pressure was managed with labetalol iv, metoprolol and the patient's amlodipine dose was increased to 5 mg.The customer stated that the patient was discharged home on (b)(6) 2024 on amlodipine 5 mg which has now been increased to 7.5 mg.The customer reported that they believed that the patient's adverse events were due to a combination of the patient's ecp treatment procedure with its rapid fluid shifts and fluid overload, the patient's pre-existing hypertension, and decreased chest wall movement due to the patient's pre-existing scleroderma.The customer stated that the patient has continued with their ecp treatments.The customer reported that the patient underwent a second ecp treatment procedure on (b)(6) 2024.The customer stated that the patient received their anti-hypertensive medication prior to their second ecp treatment procedure.The customer reported that for the patient's second ecp treatment procedure the patient's whole blood processed volume was reduced to 750ml and the collect and return rate were reduced to 20 ml/min.The customer stated that the patient's fluid balance at the end of their second ecp treatment procedure was +315ml and the patient tolerated their second ecp treatment procedure well.No product was returned for investigation.
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as an mdr due to the patient's hospitalization and also due to the medical intervention of the oxygen and anti-hypertension medications 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 service was requested by the customer for this adverse event.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since 19-sep-2017.As part of the review, it was determined that the instrument's last service prior to the event was on 24-jul-2024.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 root cause for the patient's dyspnea, oxygen desaturation, tachypnea, tachycardia, and hypertension could not be determined as there was no reported instrument issue, no product was returned for investigation, and no instrument service was requested by the customer or performed by therakos as a result of this incident.The customer reported that they believed that the patient's adverse events were due to a combination of the patient's ecp treatment procedure with its rapid fluid shifts and fluid overload, the patient's pre-existing hypertension, and decreased chest wall movement due to the patient's pre-existing scleroderma.The cellex operator' manual, section 2-1 administering therakos® photopheresis states aabb guidelines recommend that the temporary extracorporeal blood volume be limited to 15% of the patient's estimated total blood volume.The patient's clinical condition at the time of therakos® photopheresis may warrant an extracorporeal blood volume of less than 15% of total blood volume to maintain haemodynamic stability.Complete assessment of the patient prior to every treatment is necessary to determine the appropriate extracorporeal blood volume and fluid balance during each treatment.In addition, the cellex operator's manual, section 5-21 rationale for changing default setup parameter settings, changing collect, return, and reinfuse flow rate limits states the instrument gradually reaches a default flow rate of 30 ml/min for the collect flow rate and 35 ml/min for the return flow rate.You may choose to set lower collect, return and/or reinfusion rate limits for an individual patient.If so, these limits may be entered and saved via the setup screen at any time during the treatment.Medical conditions that warrant lower flow rate limits include, but may not be limited to: cardiac insufficiency, pulmonary insufficiency, renal insufficiency, diabetes, hypertension, hypotension, edema, fragile veins, and low body weights.Trends were reviewed for complaint categories, dyspnea, oxygen desaturation, tachypnea, tachycardia, and hypertension.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: dyspnea, low oxygen saturation, appropriate term/code not available:tachypnea, tachycardia, and high blood pressure/hypertension.(b)(4).S.K.26-nov-2024.

• Brand Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Common Device Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer (Section G): MACK MOLDING COMPANY; 608 warm brook rd; arlington VT 05250
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 20789064
• Report Number: 3013428851-2024-00136
• Device Sequence Number: 12486469
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170331
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 11/26/2024

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 Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 55 KG