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

Model Number CELLEXUSA

Device Problem Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 04/26/2021

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 20% albumine that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.The instrument has been located at the customer's site since (b)(6) 2016.As part of the review, it was determined that the instrument's last service prior to the event was on 15-feb- 2021.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 inspected by a mallinckrodt service technician at the customer's site.The service technician checked the load cells for both the treatment and return bags as well as the load cell hooks.No technical issues were found as the load cells were within specification and the pump volumes were within specification as well.The system checkout procedure was then successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.The service technician stayed and observed a patient treatment (the same patient for whom this incident has been reported).The instrument primed the cellex kit as expected and the patient's treatment was successfully completed without any alarms or issues.The smart card was returned for investigation.The smart card data was reviewed and prime was successfully completed.Collection was started in single needle mode and switched to double needle mode at 119 ml of whole blood processed.The operator raised the collect and return flow rates to 40 ml/min and 45 ml/min, respectively two minutes after the purging air phase of the treatment.The operator raised the collect and return flow rates again to 50 ml/min and 60 ml/min, respectively ten seconds later.Two alarm #16: collect pressure alarms then occurred.The operator decreased the collect flow rate thirty seconds later to 35 ml/min with the return flow rate remaining at 60 ml/min.Thirty seconds later the operator changed the return flow rate to 0 m/min with the collect flow rate remaining at 35 ml/min.A few seconds later, the collect flow rate was changed again to 40 ml/min with the return flow rate remaining at 0 ml/min.Twelve minutes later an alarm #19: fluid balance limit alarm occurred as expected at 867 ml of whole blood processed as the patient's fluid balance limit was at -501 ml.The operator changed the instrument's lower fluid balance limit to -600 ml and continued with the treatment.The operator switched to single needle mode when the patient's fluid balance reached -523 ml.The return flow rate was still set at 0 ml/min.The operator increased the return bag threshold value to 150 ml.The return pump was on keep vein open and the centrifuge bowl had stopped as the return time was calculated as > seven minutes.Approximately one minute later, the operator raised the return rate from 0 ml/min to 60 ml/min.An alarm #16: collect pressure alarm then occurred and the target for whole blood processed was reduced to 1200 ml with 895 ml of whole blood processed.An alarm #17: return pressure alarm then occurred for pressure below the lower limit.The operator reduced the return bag threshold to 100 ml after 955 ml of whole blood processed.The buffy coat collection began after 1161 ml of whole blood processed.The operator pressed the end buffy button after 83 ml of buffy volume had been collected.Photoactivation and refusion of the treated cells took place and the treatment ended automatically, as expected with the patient's final fluid balance limit of +338 ml.The alarm #19: fluid balance limit alarm occurred as expected as the patient's fluid balance, -501 ml, fell below the instrument's preset fluid balance limit of +/- 500 ml.The root cause for the alarm #19: fluid balance limit alarm and the patient's tachycardia and hypotension was most likely use error as the operator decreased the return flow rate to zero in the beginning of the treatment thus the patient was not receiving any blood return for twelve minutes while blood collection was occurring at 40 ml/min.Trends were reviewed for complaint categories alarm #19: fluid balance limit, tachycardia, 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: tachycardia and low blood pressure/ hypotension.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced both tachycardia and hypotension during an ecp treatment procedure on (b)(6) 2021.The customer stated that an alarm #19: fluid balance limit alarm occurred during the patient's ecp treatment.The customer reported that the patient had an episode of tachycardia at the time of this alarm with a pulse of 150.The customer stated that the patient's blood pressure at the time of this alarm was 73/51.The customer reported that the patient was then administered 100 ml of 20% albumine and the patient felt better.The customer reported that there were no alarms during the priming of the cellex kit and no other alarms occurred during the patient's treatment.The customer stated that the patient was connected in double needle mode with flow rates of 50 ml/min for collection and 55 ml/min for return.The customer reported that at the time of the alarm #19: fluid balance limit alarm, the return bag was 3/4 full with the patient's blood.The customer stated that as soon as the patient's fluid balance reached - 500 ml, the patient's ecp treatment procedure was changed to single needle mode.The customer reported that the treatment's whole blood processed volume was also reduced to 1200 ml and the patient's ecp treatment procedure was then completed without any further alarms or issues.The customer reported that the patient was in stable condition.The customer requested service for the instrument.The smart card 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: 11891527
• MDR Text Key: 266065950
• Report Number: 2523595-2021-00053
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)160419
• 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: 05/26/2021

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• 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: 46 YR
• Patient Weight: 50