MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); Leak/Splash (1354); Issue With Displayed Error Message (2967)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e349 was reviewed.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.This assessment is based on information available at the time of the investigation.At the time of this report, the analysis of the returned kit photos is still in progress.A supplemental report will be filed when the analysis of the kit photos is complete.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a tubing leak at the collect pump tubing segment after 1241ml of whole blood processed.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the patient was in stable condition.The customer stated that there were no alarms prior to the leak.The customer reported that they had no trouble loading the kit onto the instrument.Photos were submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the leak.However, the location of the leak could not be determined based on the information provided.Neither the cause nor the root cause for the leak could be determined based on the review as no manufacturing defects were identified.A review of the device history record did not identify any related nonconformances.No further action required.This investigation is now complete.(b)(4).Device not returned to manufacturer.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• 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 ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6183438
• MDR Text Key: 63072135
• Report Number: 2523595-2016-00278
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E349(17)180901
• 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,Followup
• Report Date: 12/16/2016

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: 09/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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: 44 YR
• Patient Weight: 53