MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Migration or Expulsion of Device (1395); Noise, Audible (3273)

Patient Problem Blood Loss (2597)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pto 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 g350 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g350 shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for this complaint category.A photograph was provided by the customer for evaluation.The photograph shows evidence of a blood leak within the pump tubing organizer (pto).The exact location of the leak within the pto cannot be identified in the customer photograph; however, it appears that the source of the leak could be from the pto filter weld or the tubing bonds inside the filter sockets.The pto filter weld and tubing bonds inside the filter sockets are 100% leak tested as a subassembly and again during finished product testing.A review of the manufacturing history log found no unscheduled maintenance associated with the pto filter welder during the manufacture of kit lot g350.A device history record review for kit lot g350 did not identify any related non-conformances, and this kit lot had passed all lot release testing.The root cause of the pto leak could not be determined based on the available information.No further action is required at this time.Investigation complete.(b)(4).

Event Description

Customer called to report an air detected alarm during buffy coat collection.The customer stated that after the alarm a "pop" was heard and it became apparent that the top right corner of the pto was leaking.The leak occurred after approximately 1500 ml of whole blood had been processed.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable.The customer returned a photo 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: 8162094
• MDR Text Key: 131381462
• Report Number: 2523595-2018-00173
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G350(17)200701
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2018
• 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