MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem Thrombosis (2100)

Event Date 01/14/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and the medical intervention of the heparin and klexane 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 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 prior to the event was on (b)(6) 2015.After this service, the instrument had passed all tests and was operational.Trends were reviewed for complaint category, thrombosis.No trends were detected for this complaint category.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: thrombosis.(b)(4).S.K.(b)(6) 2019.

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced a thrombosis following a treatment procedure.The customer stated that the patient underwent a successful ecp treatment procedure on (b)(6) 2016.The customer reported that the patient's thrombosis was detected on (b)(6) 2016 when the patient's central venous catheter would not take or give fluids normally.The customer stated that the patient also had swelling in both her neck and under her arm.The customer reported that both a catheter thrombosis and an upper vena cava thrombosis were detected.The customer also stated that the veins in the patient's chest had become more pronounced.The customer reported that the patient's symptoms had started a few weeks prior to their thrombosis diagnosis.The customer stated that the patient's central venous catheter was removed on (b)(6) 2016.The customer reported that the patient was hospitalized from (b)(6) 2016 to (b)(6) 2016.The customer reported that a heparin iv infusion was administered to the patient on (b)(6) 2016 while the patient was in the hospital.The customer stated that afterwards the patient was given klexane sc, and this medication is still ongoing.The customer reported that the patient underwent 16 two-day ecp treatment procedures prior to their thrombosis diagnosis.The customer stated that each of the patient's ecp treatments procedures used heparin (10000 iu/nacl 500 ml) as the anticoagulant at a 10:1 ratio.The customer reported that the patient was treated without a blood prime and 1500ml of whole blood was processed for each treatment.The customer stated that the patient had both a central venous catheter and a peripheral cannula.The customer reported that the patient's ecp treatment procedures were stopped due to the patient's thrombosis.The customer stated that the patient's graft versus host disease medication was also stopped on (b)(6) 2016.The customer did not want to take a stand on whether the patient's ecp treatment procedures could have caused or contributed to the patient's thrombosis or if the patient's thrombosis could have been due to the patient's underlying condition.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: 8512494
• MDR Text Key: 141914345
• Report Number: 2523595-2019-00058
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2019

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 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: 04/03/2019
• Initial Date FDA Received: 04/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 17 YR
• Patient Weight: 36