MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome membrane leak.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 f127 was conducted.There were no non-conformances.This lot met all release requirements.A review of f127 for the reported issue shows no trends.Trends were reviewed for complaint categories alarm #16: collect pressure, alarm #18: system pressure, pressure dome membrane leak.No trends were detected for each complaint category.The smartcard and customer photographs were returned for analysis.Review of the data on the returned smartcard and complaint description confirmed the occurrence of a system pressure alarm.The smartcard data also showed that there had also been several air detected warnings throughout the procedure.The smartcard data also verified that air was seen in all five air detectors.The photographs were then investigated and it showed evidence that the system pressure dome was not locked down onto the system pressure sensor.Further analysis confirmed that the diaphragm of the system pressure dome had been partially dislodged but it could not be determined unequivocally why that latch was not locked down.The root cause of the blood leak at the system pressure dome could not be determined.No further action is required at this time.This investigation is now complete.Investigation complete.

Event Description

Customer sent a report regarding a leak around the system pressure dome early in the treatment.The procedure had been ended and the blood in the return bag was returned to the patient.The nurse mentioned that there had been an alarm #: 16 collect pressure due to poor access and an alarm #18: system pressure.Moments after the alarm is when the leak was identified.The patient was in stable condition and no medical intervention was needed.The patient received a successful treatment immediately after the incident using a new kit.The customer provided the smartcard, and photos to be sent back for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7013485
• MDR Text Key: 93079772
• Report Number: 2523595-2017-00199
• 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
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• 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: 65 YR