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

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A medical device report (mdr) has been completed for this complaint file as the complaint category, pressure dome membrane leak, was determined to be a reportable device malfunction.Pressure dome membrane leak is a malfunction associated with the kit; therefore, this mdr is specific to the kit.A batch record review for kit lot f104 was performed.There were no non-conformances related to the reported complaint.Lot f104 met all release requirements.A review of f104 determined there were no trends for the reported issues.Trends were reviewed for complaint categories, pressure dome membrane leak and alarm #16: collect pressure.No trends were detected for each complaint category.Complaints will continue to be monitored through tracking and trending.If a trend is detected, further investigation will be conducted.The complaint issues could not be verified as no product was returned for investigation.This assessment is based on the information available at the time of the investigation.The complaint issues could not be confirmed based on the information provided by the customer, the batch record review, and complaint trending.No further action is required at this time.Investigation complete.Mc: 019892 m.W.06/09/2017.

Event Description

The customer reported that the collect pressure dome had "popped out" and subsequently the membrane leaked sometime during the beginning of the ecp treatment.The blood within the kit was not returned to the patient.The patient was in stable condition at the time of the event and was not impacted by the incident.The customer indicated that the complaint kit is not available for evaluation as it had been discarded.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; hampton NJ
• Manufacturer (Section G): THERAKO, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; p.o. box 9001; hampton, NJ 08827
• MDR Report Key: 6632119
• MDR Text Key: 77523458
• Report Number: 2523595-2017-00106
• 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
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• 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: 52 YR