MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

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

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot f207.Was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f207 for the reported issue shows no trends.Trends were reviewed for complaint categories, alarm #46: accelerometer system alarm and drive tube leak/break.No trends were detected for these complaint catagories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the customer provided photos is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report alarm #46: accelerometer system alarm during buffy coat collection.The customer was able to complete the treatment successfully but when the customer released the kit they had noticed blood at the drive tube.There are customer provided photos to further investigate the incident being reported.The patient was in stable condition and there are no further questions or concerns regarding this issue.

Manufacturer Narrative

Analysis is based off of the customer supplied photos.The photos that were provided by the customer shows evidence of the blood on the external source of the drive tube.Further investigation of the photos shows that there appeared to be a mark or possibly a cut on the over molded strain relief.It is unclear whether this is a breach or an accumulation of blood from elsewhere on the drive tube.Each kit is 100% leak tested during manufacturing at the dual occlusion leak tester.Based on the customer supplied photos, the root cause of the failure mode cannot be determined.Investigation complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; hampton NJ
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road po box 9001; hampton, NJ 08827
• MDR Report Key: 6652971
• MDR Text Key: 78145812
• Report Number: 2523595-2017-00105
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/13/2017

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: 02/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 06/19/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• 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: 67