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

Lot Number D104 - KIT

Device Problems Break (1069); Leak/Splash (1354); Device Slipped (1584); Device Displays Incorrect Message (2591)

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

Event Date 04/15/2015

Event Type  malfunction  

Event Description

Customer called to report a centrifuge bowl leak/break during procedure: at around 200ml wbp there was an alarm #18: system pressure and the bowl break came immediately after.Customer believes the bowl was loose.Customer confirmed there was no visible damage in the centrifuge chamber, it was cleaned and a new kit was installed.Patient was stable and will receive a new treatment.Customer did not return product for investigation.Photos were provided for analysis.

Manufacturer Narrative

Lot d104 was reviewed.There were no non-conformances.This lot met all release requirements.Device was used for treatment.Uvadex was administered.However, this incident is not related to uvadex.The uvadex lot number was not reported; therefore no batch record review was performed.Trends were reviewed for all complaint categories and no trend was detected for alarm #18: system pressure nor for centrifuge bowl leak/break.A corrective and preventive actions was initiated for alarm #18: system pressure and is now closed.A corrective and preventive action has been initiated for centrifuge bowl leak/break.The assessment is based on information available at the time of the investigation.The photo analysis is still in progress at the time of this report.A supplemental report will be filed when this investigation is complete.(b)(4).

Manufacturer Narrative

Photos were provided by the reporter for evaluation.Based on the analysis, a leak was confirmed, but the leak site or cause of the leak could not be determined.There is no mark from the drive tube impacting the centrifuge wall, which would be an indication that the upper bearing stop delaminated.Both bearings were still within the closed retainers, which indicates that the drive tube was installed correctly.The drive tube does not appear to be twisted.The upper and lower bowl components appear intact, which indicates no separation at their weld joints.As the leak site cannot be determined from the information provided; the cause of leak is unknown.There is no apparent break, as described, in the outer bowl in the photos provided.No manufacturing defect identified.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4766649
• MDR Text Key: 5797571
• Report Number: 2523595-2015-00145
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

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: 01/01/2017
• Device Lot Number: D104 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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: 63 YR
• Patient Weight: 78