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 Bacterial Infection (1735); Fever (1858)

Event Date 10/31/2017

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 antibiotic treatment that was given to the patient as well as the removal of the patient's catheter.This case is also reportable as a mdr due to the patient's hospitalization.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 product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since 26-apr-2010.As part of the review, it was determined that the instrument's last service was on 2-jun-2017.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 categories, central line infection and fever.No trends were detected for these complaint categories.Based on the available information it is unlikely that the patient's possible catheter infection could have been due to the ecp device.If an infection was caused by the ecp device then the infection should have shown in the culture of the tip (the part of the line that was inside of the patient's body) and not just in the lumens (that dangle on the outside of the body).But no infection was noted in the culture of the tip.The type of staphylococcus (staphylococcus epidermis) that was found in the culture of the lumens, is found on the skin and is a common bacteria.Comparing the results of the culture of the catheter tip to the cultures of the lumens suggests improper handling/cleaning of the central line when being accessed.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: infection, bacterial and fever mc (b)(4), (b)(4) 2018.

Event Description

The customer emailed to report that a clinical study patient developed a possible catheter infection.The customer stated that the patient's last extracorporeal photopheresis (ecp) treatment was on (b)(6) 2017 and the patient had undergone a total of thirty ecp treatments.The customer stated that the patient went to the emergency room on (b)(6) 2017 due to a presenting fever of 38.4°c.The customer reported that the patient exhibited no other symptoms.The customer stated that in the emergency room, a peripheral iv was started, the catheter protocol was performed, and an empirical antibiotic therapy was started with piperacillin/ tazobactam at 300 mg/kg/day, without amikacin since the patient did not present with neutropenia on the labs that were performed twelve hours earlier.The customer stated that the patient's catheter was removed and the catheter protocol was performed on (b)(6) 2017.The results indicated that the peripheral qualitative was positive for s.Epidermidis.In addition, the customer reported that the peripheral quantitative and central vascular catheter tested positive for s.Epidermidis: peripheral 1 cfu/ml, distal catheter 8 cfu/ml, and proximal catheter > 1000 cfu/ml.The customer stated that the catheter tip culture on (b)(6) 2017 resulted in < 15 cfu of coagulase-negative staphylococci which is an insignificant positive.The customer reported that antibiotic treatment was started with systemic vancomycin due to the suspicion of a catheter infection.The customer reported that the patient was admitted to the hospital ward on (b)(6) 2017 under strict clinical and vital sign monitoring.The customer stated the patient remained stable, afebrile, and in good general condition during the stay.The customer reported that the vancomycin was maintained until (b)(6) 2017, when the patient's antibiotic therapy was switched to teicoplanin due to issues with the patient's venous access.The customer stated that on (b)(6) 2017, the patient completed one week of antibiotic therapy and the therapy was then discontinued.The customer reported that given the patient's good clinical course, it was decided to discharge the patient to his home on (b)(6) 2017 with a follow up at the day hospital on (b)(6) 2017.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: 7347029
• MDR Text Key: 102719413
• Report Number: 2523595-2018-00044
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2018

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: Physician
• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 24 MO
• Patient Weight: 15