MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e135 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e135 for the reported complaint issue shows no trends.Trends were reviewed for complaint category, bag 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 distributor reported a bag leak by email.The distributor's email stated that the treatment bag was filled with air during photoactivation.The distributor reported that the treatment bag finally ruptured and "the blood flown away." the distributor stated that the treatment was aborted with no blood/products returned to the patient.The distributor reported that the patient was ok.Photos were submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photo confirmed that the treatment bag contained air.However, the root cause for the air in the treatment bag during the photoactivation phase of the treatment could not be determined based on the information provided.The report that the treatment bag "ruptured" and leaked could not be confirmed based on the photo that was submitted for investigation, as the photo only showed the treatment bag intact.No manufacturing related defects were noted in the review of the photo.A review of the device history record (dhr) for this kit lot did not show any related nonconformances or trends; and this kit lot had successfully passed all lot release testing requirements.No further action required.This investigation is now complete.Correction: manufacture date: 07/30/2016.(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: 6220327
• MDR Text Key: 64025077
• Report Number: 2523595-2017-00001
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: E135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2016
• 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: 55 YR
• Patient Weight: 100