MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

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

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 f111 was conducted.There were no non-conformances.This lot met all release requirements.A review of f111 for the reported issue shows no trends.Trends were reviewed for complaint categories tubing leak, alarm #16: collect pressure.No trends were detected for each complaint category.The complaint photographs were provided for analysis.The tubing leak reported by the customer has been verified as the provided photographs showed that the leak appears to be coming from a tubing line.However, the nature of the tubing damage cannot be determined through inspection of the photographs.Cellex kits are 100% leak tested prior to packaging and release; therefore, it is unlikely the reported tubing leak issue was present during product creation.No manufacturing related defects were identified during the evaluation.The cause of the tubing leak during the treatment could not be determined." investigation complete.(b)(4).

Event Description

Customer reported a tubing leak during procedure.The leak was noticed at the start of the procedure, during the purging air.Customer said that an alarm had sounded and was immediately reset.Customer stated they were unsure which alarm occurred but thinks it may have been an alarm #16: collect pressure.The treatment was aborted and the customer stated he manually returned the content of the return bag with a transfusion set.The patient was in stable condition and is undergoing a new treatment.Customer has provided photos of the incident to be investigated.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 6868740
• MDR Text Key: 86640343
• Report Number: 2523595-2017-00174
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2017

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: Physician
• Device Expiration Date: 02/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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: 68 YR
• Patient Weight: 62