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

Lot Number B345-KIT

Device Problems Material Separation (1562); Device Displays Incorrect Message (2591)

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

Event Date 01/08/2014

Event Type  malfunction  

Event Description

Customer called on (b)(6) 2014 to report a patient treatment performed monday, (b)(6), 2014 that had a clotted bowl with a banding appearance.Customer stated the bowl had the same appearance as the treatment last week that resulted in a bowl break.Customer stated the treatment was aborted and no blood was returned to the patient.On (b)(6), 2014, 2:36 pm est: css called customer to request clarification on the initial call documented above.On (b)(6): customer called back to report that after further inquiry into the incident, customer found banding may refer to "weird" separation in the bowl at the time of the procedure since they were not able to resolve the return pressure alarms.Customer stated that they noted clotting in the centrifuge bowl when unloading the kit from the machine.Css asked if there were any products returned to the patient.Customer stated no there were no products returned to the patient due to return pressure alarms as well as clotting in the bowl.Css informed customer that return pressure alarms were not reported to therakos at the time of the call.Customer stated that he was calling on behalf another nurse who was actually performing/overseeing the procedure.

Manufacturer Narrative

Batch record review of lot b345 was conducted.There were no non conformances related to this lot.Lot met release requirements.Trends have been reviewed for return pressure complaint category and no trend has been detected.The assessment is based on info available at the time of the investigation.No product was returned by the customer.Our investigation did not indicate that a malfunction has occurred.However, as the customer perceived that the product might have malfunctioned and believed that the centrifuge might break, and therakos was not able to confirm that the product did not malfunction, out of an abundance of caution, therakos is reporting this incident.Refer to capa# (b)(4) for late reporting rationale.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 220 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east suite 140; bridgewater, NJ 08807
• MDR Report Key: 3905773
• MDR Text Key: 4678662
• Report Number: 2523595-2014-00147
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2014

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: Health Professional
• Device Expiration Date: 11/01/2015
• Device Lot Number: B345-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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