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

Catalog Number CELLEX

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

Patient Problems Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2024

Event Type  Injury  

Event Description

The customer reported that a blood prime extracorporeal photopheresis (ecp) patient experienced hypotension, abdominal pain, and nausea during their ecp treatment procedure.The customer reported that the patient was being treated with ecp for graft versus host disease (gvhd).The customer stated that the patient experienced hypotension, abdominal pain and nausea during the buffy coat collection phase of their blood prime ecp treatment procedure.The customer reported that the patient has a history of high blood pressure and is taking the medication, vasotec, for their high blood pressure.The customer stated that the patient did take their hypertension medication dose prior to starting their ecp treatment procedure.The customer reported that the patient's pretreatment blood pressure was 125/85 on their left arm.The customer stated that the patient's blood pressure steadily dropped, 96/89, 89/55, 88/37, 80/52, to 79/43 (onset of patient's symptoms) during the buffy coat collection phase of their blood prime ecp treatment procedure.The customer reported that the patient was administered iv saline and their blood pressure rose to 108/78.The customer stated that they were then able to complete the patient's blood prime ecp treatment procedure with 699mls of whole blood processed (wbp) from the patient.The customer reported that even though the patient's blood pressure increased after the administration of the iv saline, the patient was still not feeling well after the completion of their blood prime ecp treatment procedure.The customer stated that the patient was then admitted to the hospital's pediatric intensive care unit (picu).The customer reported that the patient was admitted to the hospital's picu due to hypotension, pneumatosis, and abdominal free air (pneumoperitoneum).The customer stated that the patient's hypotension responded well to fluid resuscitation and did not require any pressors.The customer reported that the patient did not require oxygen, as the patient did not have any respiratory distress.The customer stated that the patient was placed on bowel rest and kept npo (nothing by mouth).The customer reported that the patient's gastrostomy tube (gt) was placed to gravity.The customer stated that the patient was on intravenous fluids (ivf) with electrolytes and was treated with antibiotics due to concerns for sepsis vs anemia while in the picu.The customer reported that the patient was transferred from the picu to the ponc (pediatric oncology unit) on 07-jan-2024.The customer stated that the patient was discharged home from the ponc on (b)(6) 2024.The customer reported that the patient has now started monthly abatacept to help manage their gvhd.The customer stated that the patient will not be continuing with their ecp treatments as this was the patient's second episode of hypotension during ecp which required picu admission.The customer stated that both the patient's ecp treatment procedure and their underlying condition caused or contributed to the patient's abdominal pain, nausea, and hypotension.No product was returned for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and to the medical intervention of the intravenous fluids (ivf) with electrolytes and the antibiotics 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.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since 04-aug-2015.As part of the review, it was determined that the instrument's last service prior to the event was on 27-jan-2023 (annual preventive maintenance).During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.In addition, the 2024 annual preventive maintenance was performed on this instrument on 10-jan-2024, a few days after the patient's event.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 adverse events 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 performed a blood prime ecp treatment procedure as recommended for this low body weight patient.Per the cellex operator's manual section 10-16 blood prime, "the patient will be isovolemic during drawing/returning when double needle mode access is used and the collect and return flow rates are identical.The patient will remain isovolemic during buffy coat if the donor prbc unit is used to displace the buffy coat and the return flow remains at the blood prime default of 0 ml/min.On average, if following the blood prime instructions, the patient will become approximately 170 ml fluid positive once the treated leukocytes are reinfused and rinseback is performed.Confirm that the patient is able to tolerate this positive fluid shift." hypotension is also a labelled side effect of the cellex photopheresis system.Per the cellex operator's manual section 2-3 adverse events, "hypotension may occur during any treatment involving extracorporeal circulation.Closely monitor the patient during the entire treatment for hypotension." trends were reviewed for complaint categories, pain, hypotension, nausea, sepsis, pneumatosis, and pneumoperitoneum.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: abdominal pain, low blood pressure/ hypotension, nausea, sepsis, pneumoperitoneum, and appropriate term / code not available:pneumatosis (b)(4).02-feb-2024.

Manufacturer Narrative

Additional information: b5.(b)(4).

Event Description

The customer reported that a blood prime extracorporeal photopheresis (ecp) patient experienced hypotension, abdominal pain, and nausea during their ecp treatment procedure.The customer reported that the patient was being treated with ecp for graft versus host disease (gvhd).The customer stated that the patient experienced hypotension, abdominal pain and nausea during the buffy coat collection phase of their blood prime ecp treatment procedure.The customer reported that the patient has a history of high blood pressure and is taking the medication, vasotec, for their high blood pressure.The customer stated that the patient did take their hypertension medication dose prior to starting their ecp treatment procedure.The customer reported that the patient's pretreatment blood pressure was 125/85 on their left arm.The customer stated that the patient's blood pressure steadily dropped, 96/89, 89/55, 88/37, 80/52, to 79/43 (onset of patient's symptoms) during the buffy coat collection phase of their blood prime ecp treatment procedure.The customer reported that the patient was administered iv saline and their blood pressure rose to 108/78.The customer stated that they were then able to complete the patient's blood prime ecp treatment procedure with 699mls of whole blood processed (wbp) from the patient.The customer reported that even though the patient's blood pressure increased after the administration of the iv saline, the patient was still not feeling well after the completion of their blood prime ecp treatment procedure.The customer stated that the patient was then admitted to the hospital's pediatric intensive care unit (picu).The customer reported that the patient was admitted to the hospital's picu due to hypotension, pneumatosis, and abdominal free air (pneumoperitoneum).The customer stated that the patient's hypotension responded well to fluid resuscitation and did not require any pressors.The customer reported that the patient did not require oxygen, as the patient did not have any respiratory distress.The customer stated that the patient was placed on bowel rest and kept npo (nothing by mouth).The customer reported that the patient's gastrostomy tube (gt) was placed to gravity.The customer stated that the patient was on intravenous fluids (ivf) with electrolytes and was treated with antibiotics due to concerns for sepsis vs anemia while in the picu.The customer reported that the patient was transferred from the picu to the ponc (pediatric oncology unit) on (b)(6) 2024.The customer stated that the patient was discharged home from the ponc on (b)(6) 2024.The customer reported that the patient has now started monthly abatacept to help manage their gvhd.The customer stated that the patient will not be continuing with their ecp treatments as this was the patient's second episode of hypotension during ecp which required picu admission.The customer stated that both the patient's ecp treatment procedure and their underlying condition caused or contributed to the patient's abdominal pain, nausea, and hypotension.In a follow-up with the customer on (b)(6) 2024 regarding the patient's pneumatosis with pneumoperitoneum condition, the customer stated that they did not believe that the patient's ecp treatments could have caused or contributed to the patient's pneumatosis with pneumoperitoneum condition.The customer reported that the patient has had long standing gastrointestinal issues and that while in the hospital in (b)(6) 2023 the patient had developed pneumatosis coli.The customer stated that they believed that the patient's pneumatosis with pneumoperitoneum condition was due to the patient's low hematocrit.The customer reported that the patient's hematocrit wasn't low according to the therakos ecp recommendations, but it was low for the patient's threshold.The customer stated that they did not have a strong opinion on whether the patient's pneumatosis with pneumoperitoneum condition was due to the patient's underlying condition.No product was returned for investigation.

• Brand Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Type of Device: 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: 18636021
• MDR Text Key: 334491779
• Report Number: 3013428851-2024-00007
• Device Sequence Number: 1
• Product Code: LNR
• 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: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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; Hospitalization
• Patient Age: 24 MO
• Patient Sex: Female
• Patient Weight: 13 KG