MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e226 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e226 for the reported complaint issue shows no trends.Trends were reviewed for complaint category pressure dome membrane leak, and no trend was detected for this category.This assessment is based on the information available at the time of the investigation.At the time of this report, the return product evaluation has yet to be completed.A supplemental report will be sent once investigation is complete.This case is reportable as a mdr due to the reportable malfunction, pressure dome membrane leak.Since the pressure dome membrane leak is associated with the kit, only one mdr will be filed for this case.(b)(4).Device not returned for investigation.

Event Description

Customer reported that as kit was unloaded, operator discovered dried blood around the collect pressure sensor and traces of more fresh blood on the return pressure sensor.Operators examined membranes, no leak could be observed.Treatment was blood prime with 750 whole blood processed (wbp) target.270 ml wbp was from the prbc unit.Treatment volume was 147 ml, 2.4 ml uvadex was injected.Photoactivation time 5.00 min.Treatment volume and 20 ml rinse back was returned to patient.There had been no alarm during treatment.Patient was stable.The kit was discarded.Photos and a video when filling the collect pressure dome with saline were provided.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the leak.Based on the photos, the pressure domes' membranes appeared to still be properly installed onto the bodies of both the collect and return pressure domes.In the photos, there were no visible slits, holes or cracks in either of the pressure domes' assemblies.The root cause for the leak could not be determined as no defects were identified in either of the pressure dome assemblies based on the information provided.The device history record (dhr) review did not result in any related nonconformances, and this lot had passed all lot release testing.A material trace of the pressure dome assemblies used to build this kit lot also did not return any nonconformances.Each pressure dome assembly is leaked tested twice during manufacturing and again as part of the whole kit before the kit is released.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; hampton NJ 08827
• 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: 6353370
• MDR Text Key: 68510969
• Report Number: 2523595-2017-00035
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/17/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: E226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• 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: 2.5 YR
• Patient Weight: 11