MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.Out of an abundance of caution, this case is reportable as a mdr due to the medical intervention of the diuretic medication that was given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the device perspective, there was no known device 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) 2014.As part of the review, it was determined that the instrument's last service was on (b)(6) 2016.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 category, other adverse event: hyperkalemia.No trends were detected for this complaint category.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: other: hyperkalemia.(b)(4).Device not returned to manufacturer.

Event Description

The customer sent an e-mail to report that a patient who was currently undergoing extracorporeal photopheresis (ecp) treatments due to heart transplant rejection was experiencing hyperkalemia.The customer also stated that the patient was diabetic as well and was being treated with insulin.The customer reported that the patient's blood prime ecp treatments had been going well.The customer stated that the patient's ecp treatments took place on (b)(6) and on (b)(6) 2017.The customer reported that this was the patient's second round of ecp treatments with that their first round ended in (b)(6) 2017.The customer stated that at several occasions during these treatments, the patient's kalium values were found to be raised.The customer reported that at one point the patient's kalium levels were so high that heart monitoring was conducted.On (b)(6) 2017, the customer stated that the blood samples that were used to determine the patient's kalium levels were taken prior to the treatment, halfway through treatment, and after the treatment.The customer reported that the patient's ecp treatments were always successfully completed and that the drug treated cells were reinfused into the patient each time.The customer stated that the patient's kalium level was already elevated prior to the patient's first ecp treatment on (b)(6).The customer reported that the patient's kalium level on this day was 4.4 mmol/l, when the normal range of kalium should be 3.5 - 4.4 mmol/l.The customer stated that the patient was being treated with the medication, spironolactone, but since this binds kalium, this medication was discontinued.The customer reported that the patient was also given diuretic medication in order to decrease their kalium level.The customer stated that on (b)(6), the patient was given insulin prior to their ecp treatment.The patient's kalium level for this day was not provided by the customer.The customer reported that the patient's highest kalium values were recorded during the (b)(6) treatment.The customer stated that patient's kalium level on this day was 6.2 mmol/l prior to the treatment and 7.0 mmol/l after the treatment.The customer reported that the patient then underwent heart monitoring overnight and this monitoring continued until the patient's next ecp treatment the following day.The customer stated that she does not know when the patient's heart monitoring started, but believed it was started soon after the ecp treatment had finished.The customer reported that on (b)(6), the patient's kalium level was 6.5 mmol/l, and the patient's treating pediatrician ordered an insulin injection be given to the patient prior to their ecp treatment.The customer stated that no additional heart monitoring was made after this point.The instrument was not returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6528502
• MDR Text Key: 73902580
• Report Number: 2523595-2017-00083
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2017

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: Nurse
• 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: 04/03/2017
• Initial Date FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2013
• 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: 12 YR
• Patient Weight: 27