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

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction photoactivation module leak.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 g328 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot g328 shows no trends.Trends were reviewed for complaint categories, photoactivation module leak and alarm #44: prime 11.No trends were detected for each complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned kit and photograph is still in progress.A supplemental report will be filed when the analysis is complete.Mc: (b)(4); p.T.(b)(6) 2018.

Event Description

The customer called to report a photoactivation module leak that was observed after the treatment procedure was completed.The customer reported they received an alarm #44: prime 11 alarm during the prime phase of the procedure.The customer reported they followed corrective actions to reset the alarm.The customer stated the treatment was completed successfully and the patient was disconnected.The customer stated when unloading the kit they noticed a leak from the photoactivation module.The customer stated the patient was stable.The customer has returned the kit and a photograph for investigation.

Manufacturer Narrative

The complaint kit, smartcard, and a photograph were returned for analysis.The customer provided photograph shows the photoactivation module and treatment bag with evidence of a blood leak.A review of the data recorded on the returned smartcard confirmed the reported occurrence of an alarm #44: prime 11 alarm.Examination of the returned kit found a leak at the tubing port where the black striped tube is connected to the photoactivation plate.The cause of the alarm #44: prime 11 alarm was the leak at the photoactivation tube port.The root cause of the leak was most likely manufacturing operator error due to a weak bond joint during the tube bonding process.Retraining has been completed for manufacturing operators who perform this operation.No further action is required at this time.This investigation is now complete.(b)(4).P.T.(b)(6) 2018.

• 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: 7876558
• MDR Text Key: 120710022
• Report Number: 2523595-2018-00138
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G328(17)200401
• 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,Followup
• Report Date: 09/26/2018

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: 04/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 09/19/2018
• Supplement Dates FDA Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2018
• 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: 60 YR
• Patient Weight: 91