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

Model Number CLXUSA

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250)

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

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pto leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.Kit lot h318 was reviewed.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h318 shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for this complaint category.The complaint kit, smart card, and a photograph were returned for evaluation.The customer supplied photograph shows a blood leak on the pump deck near the return pump.A review of the returned smart card data verified that the treatment was successfully completed and blood was returned to the patient.Examination of the returned kit found dried blood on the lower right hand corner of the pto.The kit was pressure tested to check for leaks, and no leaks were found.The reported blood leak is verified based on the customer provided photograph and dried blood observed within the pto.However, the exact source of the leak could not be identified as pressure testing of the returned kit did not identify any leaks.As a result, a root cause for the pto leak could not be determined based on the available information.No further action required at this time.This investigation is now complete.Mc: (b)(4).B.K.: (b)(6) 2019.

Event Description

The customer called to report that they experienced a pump tubing organizer (pto) leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated the blood leak was observed near the return pump after approximately 1500 ml of whole blood had been processed.In addition, the customer stated there were no cellex instrument alarms prior to the pto leak.The patient was reported to be in stable condition.A photograph of the complaint issue was provided by the customer for evaluation.In addition, the complaint kit, with smart card, was returned for evaluation.

• 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: 8966907
• MDR Text Key: 213420475
• Report Number: 2523595-2019-00099
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H318(17)210301
• 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: 09/05/2019

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: 03/01/2021
• Device Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Device Lot Number: H318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• 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: 58 YR