MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Thrombus (2101)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction clot observed in the return line.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot g374 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g374 for the reported issue shows no trends.Trends were reviewed for complaint categories, clot observed and alarm #17: return pressure.No trends were detected for each complaint category.Photographs were provided by the customer for evaluation.The smartcard was not returned; therefore, the alarm #17: return pressure could not be verified.A review of the photographs confirm clotting in the return bag as reported by the customer.The customer reported seeing a clot in the return line, however the photographs provided do not show the return line and therefore clotting in that location cannot be verified.The customer reported using 10,000 units of heparin in 500ml of normal saline, the default anticoagulant (a/c) ratio for the cellex photopheresis system.Section 2-9 of the cellex operators manual (1460415 rev 5.0) on anticoagulant states "caution: individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment.The physician should review the patient's medical condition, medications and platelet count at the time of treatment and use clinical judgement to establish the optimal heparin dosage for each patient." the root cause for the clot observed could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer called to report clots observed in the return line and return bag during the treatment procedure.The customer stated they received an alarm #17: return pressure alarm and flushed the patient's access in an attempt to resolve the alarm.The customer received another return pressure alarm and disconnected the return line to run a saline bolus through the return line.The customer stated when performing the saline bolus they noticed a clot in the return line.The customer stated they inspected the kit and found further clotting in the return bag.The customer aborted the treatment and did not return blood to the patient.The customer reported the patient was stable.The customer returned photographs for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• 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: 8370708
• MDR Text Key: 139100216
• Report Number: 2523595-2019-00037
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G374(17)201001
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR