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

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

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

Event Date 12/07/2018

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.No kit lot number was provided; therefore, no batch record review could be performed.Trends were reviewed for complaint categories, pressure dome membrane leak and kit installation/removal failure.No trends were detected for each complaint category.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Section 9-6 of the therakos¿ cellex¿ photopheresis system operator's manual states "the integrity of pressure monitoring will be compromised if the pressure domes are removed after prime." additionally section 4-18 and section 9-9 of the therakos cellex photopheresis system operator's manual states: "do not remove any pressure domes during a treatment.Please call the therakos hotline for assistance as needed during troubleshooting events." a review of the customer's complaint description identified that the customer had removed or manipulated the system pressure dome during the treatment.The root cause of the pressure dome membrane leak is most likely the end user removing the pressure domes after prime was completed.The customer was verbally informed not to remove the pressure domes once a prime is completed.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.Mc: (b)(4).(b)(6) 12/21/2018.

Event Description

The customer called to report a pressure dome membrane leak during the treatment procedure.The customer stated to save time they loaded a kit onto the instrument and primed the instrument outside of the treatment room.The prime was completed, then the nurse removed the pressure domes from the pressure transducers and powered off the instrument.The customer stated they then moved the instrument into the treatment room, reinstalled the pressure domes, and powered the instrument on.The customer stated within 5 minutes of starting the treatment they noticed a pressure dome membrane leak around the centrifuge pressure sensor.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable and returned the following day for treatment.The customer did not return product for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 8189853
• MDR Text Key: 131386048
• Report Number: 2523595-2018-00178
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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