MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

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

Patient Problems Diarrhea (1811); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Tachycardia (2095); Weakness (2145); Sweating (2444); Abdominal Cramps (2543); No Code Available (3191)

Event Date 05/13/2020

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 oxygen, albumin 5% bolus, normal saline, phenylephrine, zofran iv, ringer solution, and albuterol sulfate 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.A device service history review could not be performed as an instrument serial number was not provided.Trends were reviewed for complaint categories hypotension, pale, sweating, almost fainted / felt faint, shortness of breath, heart rate increased, decreased mentation, weakness, abdominal cramping, nausea, and diarrhea.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: hypotension, sweating, dyspnea, tachycardia, weakness, abdominal cramping, nausea, diarrhea, and no code available: pale, almost fainted / felt faint, and decreased mentation.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced hypotension, paleness, sweating, almost fainted / felt faint, shortness of breath, heart rate increase, decreased mentation, weakness, abdominal cramping, nausea, and diarrhea during a treatment procedure.This patient is a participant in the (b)(6) study ((b)(4)).The customer stated that the patient became hypotensive at 15:00 during their ecp treatment procedure on (b)(6) 2020 with a systolic blood pressure in the 50s.The customer reported that the patient appeared pale and diaphoretic.The customer stated that the patient complained of being lightheaded, short of breath, and in distress.The customer reported that the patient also exhibited a mild decrease in mentation with generalized weakness.The customer stated that the patient's ecp treatment procedure was paused.The customer reported that the patient was then given oxygen and placed in a supine position.The customer stated that a 250 ml iv bolus of normal saline was also given to the patient with no change in the patient's blood pressure.The customer reported that the patient's ecp treatment procedure was then aborted with blood returned to the patient.The customer stated that the acute care team was called in and a 250 ml bolus of 5% albumin as well as 1 liter of normal saline were administered to the patient.The customer reported that 1000 mcg of phenylephrine was also administered to the patient with produced an improvement in the patient's blood pressure.The customer stated that the patient's systolic blood pressure had increased to the 90s.The customer reported that the patient also complained of nausea and zofran iv was administered to the patient.The customer stated that there was no rash visible and the patient did not complain of either wheezing or stridor.The customer reported that patient was transported to emergency room department with both improved mental status and vital signs.The customer stated that while in the emergency room department, the patient was found to have mild tachycardia with regular rhythm and no added sounds.The customer reported that the patient was also tachypneic with abdominal breathing, end-expiratory wheezing in all fields, and decreased breath sounds on the right.The customer stated that the patient also complained of abdominal cramping primarily on the right upper quadrant of his abdomen, which the patient stated he gets about once a month along with diarrhea.The customer reported that a chest ct was performed which was negative for a pulmonary embolism.The customer stated that the patient did not exhibit any lower extremity edema and had equal pulses in all their extremities.The customer reported that the patient did not have any chest pain, productive cough, fever, or other recent changes to his medications.The customer stated that the patient also had a negative covid 19 test.The customer reported that they believed that the patient was experiencing an asthma exacerbation given the patient's mild decrease in air movement with wheezing thus albuterol sulfate (2 puff) was administered to the patient and a chest x-ray was also performed.The customer stated that the patient also received a troponin levels test and an ecg.The customer stated that the patient received additional fluids, ringer solution (total of 1500 ml), while in the emergency room department as the patient was still experiencing diarrhea.The customer reported that both the patient's heart rate and blood pressure stabilized after the additional fluids.The customer stated that all of the patient's vital signs returned to within normal limits and the patient was discharged from the emergency department at 21:35 on (b)(6) 2020.The customer reported that the emergency room's physician stated that the patient's hypotension was likely due to a combination of hypovolemia and dehydration due to their diarrhea given that the patient's heart rate and blood pressure improved with fluids.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• 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 ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 10457567
• MDR Text Key: 212979059
• Report Number: 2523595-2020-00096
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• 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,study
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2020

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?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/26/2020
• 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): Required Intervention
• Patient Age: 68 YR