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

Lot Number E133-KIT

Device Problems Increase in Pressure (1491); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

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

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e133 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 #17: return pressure and clot observed.No trends were detected for these complaint categories.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 reported an alarm #17: return pressure alarm that occurred around 300ml of whole blood processed in a double needle mode treatment.The customer stated that the alarm kept re-occurring and could not be reset.The customer reported that there had been no previous alarms.The customer stated that the return pressure was extremely high.The customer reported that the return line was disconnected from the patient and flushed with a saline bolus.The customer stated that the treating physician decided to search for a better return access.The customer reported that they would proceed in single needle mode while the new catheter was being placed.However, the customer stated that as soon as the lines were reconfigured into single needle mode, the alarm #17: return pressure alarm immediately posted again with the same extreme pressure.The customer reported that no kinks or obstructions were observed within the kit.The customer stated that the treating physician then noticed clots in both the patient's return and collect catheters.The customer reported that the anticoagulant line was correctly installed with 15000iu heparin in 500ml 0.9% nacl.The customer stated that since the alarm #17: return pressure alarm could not be resolved, the treatment was aborted with no blood/product returned to the patient.The customer reported that the patient was in stable condition.The customer stated that the kit was replaced and the patient underwent a new treatment that was completed without any problems.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): 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: 6091454
• MDR Text Key: 60026347
• Report Number: 2523595-2016-00251
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2018
• Device Lot Number: E133-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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: 69 YR
• Patient Weight: 81