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

Lot Number D372-KIT

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d372 was conducted.There were no non-conformances associated with this lot.The lot met release requirements.The (b)(4) lot number was not provided as it was not administered.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or non-conformances related to the complaint were noted.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber) and drive tube leak/break.No trends were detected for these complaint categories.However, a corrective and preventive action has already been initiated for the investigation of drive tube leak/break.A photo analysis was conducted for this complaint.A review of the photographs confirmed the drive tube damage and leak.The root cause of the leak was upper bearing stop delamination which allowed the drive tube to rub against the walls of the centrifuge chamber.The drive tube was then worn away causing the damage and ultimately the leak.A review of the device history record did not identify any related non-conformances.Corrective actions have already been initiated to address the potential root causes of drive tube delamination.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a drive tube leak after 489ml of whole blood processed in dual needle mode.The customer reported that the bearings were still in the clips, but the drive tube had elongated and hit the side of the instrument causing it to crack.The customer stated that the alarm #7: blood leak (centrifuge chamber) alarm had occurred.The treatment was aborted.The patient was reported to be in stable condition, and was started on a new treatment with another instrument.The customer stated that their internal biomed will look at the instrument.Pictures were submitted for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5504284
• MDR Text Key: 40854377
• Report Number: 2523595-2016-00054
• Device Sequence Number: 1
• Product Code: LNR
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/18/2016

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: 12/01/2017
• Device Lot Number: D372-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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: 71 YR