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

Model Number NOT APPLICABLE

Device Problems Air Leak (1008); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 11/10/2017

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.A batch record review for kit lot f316 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f316 for the reported issue shows no trends.Trends were reviewed for complaint categories, tubing leak and alarm #1: 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)(6).

Event Description

The customer called to report a tubing leak during the treatment procedure.The customer stated at approximately 150 ml of whole blood processed, they received an air detected alarm.The customer checked the collect line and observed air in the line, then noted blood leaking from the collect site.The customer stated they were using extension tubing, and could not determine if the leak was coming from the collect line component of the kit or the extension tubing that was used.The extension tubing used by the customer is not an item supplied or manufactured by therakos.Although the location and cause of the leak could not be determined, this blood leak is being reported as the case may match a reportable malfunction if the leak occurred in the collect line.The customer aborted the treatment and did not return blood to the patient.The customer did not return product for investigation.

Manufacturer Narrative

Correction: manufacturing site address revised.Device available for evaluation? yes.The kit segments of the collect and anticoagulant tubing lines, and collect line luer were returned for investigation.The smartcard was not returned therefore no alarms could be verified.The returned kit components showed evidence of blood indicating they had been used.The returned component assembly was cleaned and pressure tested using a syringe to apply pressure to the collect line luer while clamping off the patient access line.Pressure was applied and the lines were held under water.No leaks were identified.A material trace of the components used to build kit lot f316 found no related nonconformances.The device history record review did not result in any related non-conformances and this kit lot had passed all lot release testing.The reported tubing leak could not be verified or replicated during the investigation, therefore no root cause could be determined.This investigation is now complete.(b)(4).

• 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 PA D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7114840
• MDR Text Key: 95769675
• Report Number: 2523595-2017-00222
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F316(17)190301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

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 Expiration Date: 03/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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