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 Abdominal Pain (1685); Hemorrhage/Bleeding (1888)

Event Date 03/07/2019

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 blood transfusion, platelet transfusion, and novoseven 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) 2018.As part of the review, it was determined that the instrument's last service was on (b)(6) 2019.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,gastrointestinal hemorrhage and abdominal pain.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: hemorrhage and abdominal pain.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced peri-rectal bleeding (pr bleeding) and abdominal pain during a treatment procedure.The customer stated that they had to reduce the patient's whole blood processed target because the patient started to complain of pain in her abdomen.The customer reported that the patient also started to experience a bit of pr bleeding.The customer stated that this was a blood prime treatment and acda was used as the anticoagulant at a 14:1 ratio.The customer reported that at the end of the treatment procedure, the patient had relatively stable parameters and their pain was better.However, the customer stated that the patient's pr bleeding had increased and the patient continued to bleed all night.The customer reported that the patient was transfused with both blood and platelets due to their bleeding.The customer stated that novoseven was also administered to the patient.The customer reported that the patient's ecp treatment procedures have been suspended and they are now treating the patient for thrombotic microangiopathy the customer stated that they were very reluctant to continue with the patient's ecp treatment procedures at the current anticoagulation ratio, but they also felt that overall the patient's ecp treatment procedures were helping the patient.The customer stated that they believed that the patient's ecp treatment procedures contributed to the patient's pr bleeding.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: 8427203
• MDR Text Key: 139043696
• Report Number: 2523595-2019-00046
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170823
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2019

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: 03/07/2019
• Initial Date FDA Received: 03/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• 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: 14 YR
• Patient Weight: 43