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

Lot Number E103-KIT

Device Problems Break (1069); Component Missing (2306); Device Displays Incorrect Message (2591); Detachment of Device or Device Component (2907)

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

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e103 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 category, centrifuge blow leak/break.No trend was detected for this complaint category.A corrective and preventive action was initiated to investigate, centrifuge bowl leak/break and is now closed but it is still being monitored.Service order report, (b)(4), feedback: the service technician cleaned the instrument and replaced the leak detector strip.The system checkout procedure was then successfully completed.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 through the capa/continuous improvement process.(b)(4).Device not returned to manufacturer.

Event Description

The customer called looking for urgent service for their instrument.The customer reported that the leak detector needed to be replaced.The customer stated that the centrifuge bowl came out of the bowl holder at approximately twenty minutes into the procedure.The treatment was aborted with no blood/products returned to the patient.On (b)(6) 2016, the customer reported that the patient was in stable condition after the procedure.The customer stated that there was an alarm when the incident occurred but she did not check to see what the alarm was.The customer reported that the leak detector strip was broken after the incident.The customer stated that the smart card was not available anymore.The kit was not returned 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: 5652093
• MDR Text Key: 46386798
• Report Number: 2523595-2016-00126
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/15/2016

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: 01/01/2018
• Device Lot Number: E103-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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