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

Model Number NOT APPLICABLE

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome membrane 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 f217 was conducted.There were no non-conformances.This lot met all release requirements.A review of f217 for the reported issue shows no trends.A material trace of the pressure dome assembly used to build lot f217 did not find any nonconformances.Trends were reviewed for complaint categories pressure dome membrane leak and alarm #26: prime 2.No trends were detected for each complaint category.A photograph analysis was conducted for this complaint.A review of the photographs confirmed the blood leak; however, the source of the leak could not be determined based on the information provided.No further action required.This investigation is now complete.(b)(4).

Event Description

Customer called to report the pressure dome detached from the red blood cell transducer during the treatment procedure resulting in a blood leak.Customer stated approximately 500 ml of whole blood had been processed at the time of the leak.The customer aborted the treatment and did not return blood to the patient.Customer stated the patient is stable.The customer will not be returning the kit; however, has 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): 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: 6931733
• MDR Text Key: 90351132
• Report Number: 2523595-2017-00182
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/09/2017

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: Nurse
• Device Expiration Date: 03/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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: 56 YR
• Patient Weight: 66