MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CLXECP

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

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.A batch record review for kit lot h164 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot h164 shows no trends.Trends were reviewed for complaint category, pressure dome membrane leak.No trends were detected for this complaint category.A photograph was provided by the customer for investigation.A review of the photograph verifies that blood is visible on the return pressure sensor.The leak site was not identifiable from the photograph.A material trace of the pressure dome housing assembly and its components used to build lot h164 did not find any non-conformances.The pressure dome is leak tested three times during manufacturing; twice at the sub-assembly level and once as part of the finished kit.It is likely a leak would have been detected during this test.A device history record review did not identify any related non-conformances.This kit lot passed all lot release testing.A root cause for the pressure dome membrane leak could not be determined from the information provided.No further action is required at this time.This investigation is complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report that they experienced a pressure dome membrane leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated the treatment was successfully completed and blood was returned to the patient.The customer reported when removing the pressure domes they observed a leak at the return pressure dome.The customer reported the patient was in stable condition.The customer discarded the kit and returned a photograph 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: 11044961
• MDR Text Key: 241931010
• Report Number: 2523595-2020-00133
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 12/21/2020

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: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: CLXECP
• Device Lot Number: H164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• 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