MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problems Itching Sensation (1943); Chest Tightness/Pressure (2463); No Code Available (3191)

Event Date 04/29/2019

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 benadryl 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.The instrument has been located at the customer's site since 25-jan-2010.The customer has their own biomedical engineer who performs all of the service for this instrument.Trends were reviewed for complaint categories, itchy, face/neck flushing, and chest tightness.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: itching, no code available: face/neck flushing, chest tightness/pressure.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced itchiness, face/neck flushing, and chest tightness during a treatment procedure.The customer stated that the patient was experiencing a heparin reaction during their ecp treatment procedure.The customer reported that at about 190ml of whole blood processed, the patient complained of itchiness in their neck area.The customer stated that they then stopped the patient's ecp treatment procedure, waited a few minutes and then resumed the patient's treatment procedure.The customer reported that within a few minutes after re-starting the patient's treatment procedure, the patient complained of itchiness again.The customer stated that they stopped the patient's treatment procedure once again, waited a few minutes and then re-started the patient's treatment procedure.The customer reported that at about 400ml of whole blood processed, the patient complained of both an itchy neck and hands as well as chest tightness.The customer stated that the patient's face had also become red.The customer reported that they then aborted the patient's treatment procedure with no blood returned to the patient.The customer stated that they administered both 500ml of normal saline and 50cc of benadryl to the patient.The customer reported that the patient was now in stable condition.The customer stated that the patient had no complaints prior to starting their treatment procedure.The customer reported that this was the patient's 51st ecp treatment procedure.The customer stated that the patient comes in for an ecp treatment procedure once every two weeks.The customer reported that when they first began treating this patient, they were using acda as the anticoagulant for the patient's ecp treatment procedures.However, the customer stated that when the patient could no longer tolerate the acda, they switched to heparin as the anticoagulant on (b)(6) 2018.The customer reported that this was the first time that the patient has had a heparin reaction.The customer stated that the dose of heparin that was used for the patient's treatment procedure was 10,000 units in 500ml normal saline.The customer reported that the heparin was prepared for them by their pharmacy.The customer stated that the heparin ratio that was used for this treatment procedure was 8:1 due to the patient's high platelet count.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, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 8652288
• MDR Text Key: 146475013
• Report Number: 2523595-2019-00062
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2009
• 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
• Patient Weight: 63