MAUDE Adverse Event Report: MACK MOLDING COMPANY CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Air Embolism (1697); Chest Pain (1776); Tachycardia (2095); Cough (4457)

Event Date 12/14/2021

Event Type  Injury  

Event Description

The risk manager from a health care facility reported that an extracorporeal photopheresis (ecp) patient experienced coughing, chest pain, tachycardia, and an air embolism during their ecp treatment procedure.The risk manager called to ask for information regarding the priming of the cellex photopheresis kit ("kit").The risk manager stated that she wanted a better understanding of the kit's priming steps in order to understand how air is expelled from the kit during prime.The risk manager reported that an incident had occurred at their health care facility after an ecp treatment was cancelled, but the kit had already been loaded onto the cellex instrument.The risk manager stated that a nurse performing the next scheduled ecp treatment on that cellex instrument was told by another nurse that the cellex instrument was `ready`.However, the risk manager stated that while the kit had been loaded onto the cellex instrument, the kit had not been primed prior to connecting the kit's return line to the patient's port-a-cath.The risk manager reported that within seconds the patient began to experience coughing, chest pain and tachycardia after the "start" prompt was selected by the nurse.The risk manager stated that the nurse stopped the patient's ecp treatment within 15 seconds and then discovered his error.The risk manager reported that the patient was given oxygen and ivs (the risk manager did not specify the type of ivs) and the patient was sent to the emergency room (er) for observation to rule out an arterial air embolism.The risk manager stated that a chest ct scan and cardiac enzyme tests were performed while the patient was in the er.The risk manager reported that the patient was diagnosed with a venous air embolism after the patient's pulse and cardiac enzymes (cardiac troponin level decreased from 20 to 9) returned to normal during the patient's er stay.The risk manager stated that the patient was not admitted as an inpatient to the hospital.The risk manager reported that the patient was discharged in stable condition from the emergency room observation after two days.The risk manager stated that the patient is still receiving ecp treatments.The risk manager reported that she felt that this issue was due to use error and not related to any type of instrument malfunction as the patient had been erroneously connected to the cellex instrument before the kit had been primed.The risk manager stated that she wanted to prevent this type of issue from recurring at her health care facility in the future by designing a policy to only open the kit and placing it on the cellex instrument after the patient had arrived at their health care facility.The risk manager reported that she was unable to locate either the kit lot number or the cellex instrument serial number from the patient's electronic medical record.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 life-threatening injury and also due to the medical intervention of the oxygen and ivs 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 instrument serial number was provided within the complaint and no product was returned for investigation.The most likely root cause for this case is use error as the nurse connected the patient to the cellex instrument before the kit was primed.The risk manager acknowledged that the nurse erroneously connected the patient to the cellex instrument before the kit had been primed.When the nurse pushed the start prompt, the cellex instrument started to prime the kit which pushed some of the sterile air within the kit to the patient.The risk manager stated that she felt that the patient's adverse events were due to use error and were not related to any type of instrument malfunction.The cellex operators manual section 5-1: operating the therakos® cellex® photopheresis system prime states "prime occurs before connecting the patient.During prime, the system initially performs a series of tests to ensure proper setup of the procedural kit and calibration of sensors as well as proper operation of pumps, lamps and fluid routing valves.All of these tests occur automatically and will generate an alarm message should a problem be found.The system then pumps anticoagulant solution and saline throughout the procedural kit, eventually filling the photoactivation module and the patient collect and return lines fully.The return and treatment bags and the centrifuge bowl will only be partially filled during prime.Some areas of the procedural kit are simply wetted with anticoagulant solution".The cellex instrument's display also informs the operator when the kit needs to be primed.The cellex operators manual section 5-9: initiating prime, states "just prior to prime, all pathways (on the cellex display) are illustrated in blue indicating there is no fluid movement within the procedural kit." in addition, the cellex display also has a banner across the top above the start prompt that prominently reads "prime - ready to prime".Trends were reviewed for complaint categories, cough, chest pain, tachycardia, and air embolism.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: cough, chest pain, tachycardia, and air embolism.(b)(4).S.K.(b)(6)2023.

Manufacturer Narrative

In addition, trends were also reviewed for complaint category, treatment error.No trends were detected for this complaint category.(b)(4) s.K.(b)(4) 2023.

• Brand Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MACK MOLDING COMPANY; 608 warm brook rd; arlington VT 05250
• 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: 17053661
• MDR Text Key: 316470623
• Report Number: 3013428851-2023-00029
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/03/2023

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 Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female