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

Lot Number E342-KIT

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e342 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber), centrifuge bowl leak/break, and drive tube leak/break.No trends were detected for these complaint categories.An issue review was opened for complaint category, centrifuge bowl leak/break.Service order report, #(b)(4), feedback: the service technician cleaned the instrument and replaced the two drive tube retainer clips and also the centrifuge leak detector strip.The system checkout procedure was then successfully performed.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).

Event Description

The customer called to report an alarm #7: blood leak (centrifuge chamber) alarm.The customer stated that a combination centrifuge bowl leak/break and drive tube leak/break occurred at the start of the treatment.The customer reported that the treatment was aborted with no blood/products returned to the patient.The customer stated that the patient was in stable condition.The customer reported that there were no alarms prior to the break.Service was requested.The kit was not returned for investigation as it had already been discarded.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6124695
• MDR Text Key: 61100723
• Report Number: 2523595-2016-00266
• 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: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/01/2018
• Device Lot Number: E342-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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: 51 YR
• Patient Weight: 93