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

Model Number NOT APPLICABLE

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

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

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction clot observed.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 category, clot observed.No trends were detected for this complaint category.A photograph was provided by the customer for evaluation.A review of the customer provided photograph confirms the reported blood clotting in the centrifuge bowl.There were no photographs provided of the clots in the hickman, collect, or return lines; therefore, no clotting could be verified in those locations.The investigation confirms the reported clotting in the centrifuge bowl; however, the root cause for this occurrence could not be determined based off of the photograph provided.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer sent an email to report a blood clot was observed during the treatment procedure.The customer stated they observed clotting in the hickman, collect, and return lines.The customer reported they were able to remove the clots by flushing the lines.The customer reported they completed the treatment and returned blood to the patient.The customer stated after the treatment was completed they noticed clotting in the centrifuge bowl component of the kit.The customer has returned a photograph for investigation.

Manufacturer Narrative

Additional patient information received.The customer used acd-a anticoagulant at a 12:1 ratio.(b)(4).(b)(6) 2018.

• 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: 7564130
• MDR Text Key: 110460263
• Report Number: 2523595-2018-00098
• 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,Followup
• Report Date: 06/20/2018

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 AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 06/03/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 06/20/2018
• 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: 61 YR
• Patient Weight: 78