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

Model Number NOT APPLICABLE

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 conducted.Trends were reviewed for complaint categories, tubing leak and alarm #52: collect line air detected.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.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(4).

Event Description

The customer called to report a tubing leak during the treatment procedure.The customer stated at the beginning of the treatment they received an alarm #52: collect line air detected and noticed blood had leaked onto the floor.The customer stated they found a hole in the collect line tubing.The customer aborted the procedure and did not return blood to the patient.The customer stated the blood loss was very small and had no influence on the patient.The customer stated the patient received treatment after on another instrument.The customer will not be returning 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: 7300940
• MDR Text Key: 101484478
• Report Number: 2523595-2018-00042
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 02/27/2018

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 Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 02/27/2018
• 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
• Patient Age: 73 YR