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 Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411)

Event Date 02/02/2021

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 iv saline that was 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 (b)(6) 2020.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6) 2020.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Trends were reviewed for complaint categories fainting and hypotension.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: low blood pressure/ hypotension and syncope/ fainting.(b)(4).S.K.(b)(6) 2021.

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced fainting and hypotension during an ecp treatment procedure on (b)(6) 2021.The customer stated that on the day of the patient's ecp treatment procedure, they started the patient's ecp treatment a bit later than expected.The customer reported that the patient was already in the ward for a long time and did not drink much water.The customer stated that the room was small and warm and many people were present.The customer reported that the patient's ecp treatment procedure was performed in double needle mode.The customer stated that there were several alarm #16: collect pressure alarms during the patient's ecp treatment procedure due to poor venous access.The customer reported that the alarm #16: collect pressure alarms were resolved with normal troubleshooting.The customer stated that at 1136ml of whole blood processed the patient fainted.The customer reported that the patient's blood pressure at that moment was 60/30mmhg.The customer stated that the patient's ecp treatment procedure was then stopped and a saline bolus was administered by the instrument to the patient.The customer reported that they stopped the saline bolus after a few milliliters.The customer stated that they then elevated the patient's feet and had the instrument return the patient's blood.In addition, the customer reported that they administered 500ml of saline iv to the patient while the instrument was returning the patient's blood.The customer stated that after the blood return and saline administration, the patient's blood pressure was 130/92mmhg.The customer reported that the patient was in stable condition and was not impacted by the incident.The customer stated that they believed that the incident was related to the patient's ecp treatment procedure and that this was a serious incident.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: 11414426
• MDR Text Key: 241849186
• Report Number: 2523595-2021-00026
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)190916
• Combination Product (y/n): N
• Reporter Country Code: MK
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2021

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 Model Number: CELLEXUSA
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• 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
• Patient Age: 40 YR
• Patient Weight: 122