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

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); Leak/Splash (1354)

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

Event Date 02/25/2020

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 h361 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h361 for the reported issue shows no trends.Trends were reviewed for complaint categories, pressure dome membrane leak, and alarm #16: collect pressure.No trends were detected for these complaint categories.The customer returned photographs and the smart card for investigation.A review of the data recorded on the smart card showed that an alarm #18: system pressure alarm occurred shortly after the purging air phase of the procedure had been completed.The reported alarm #16: collect pressure alarm was not verified.Review of the customer provided photographs confirmed that a pressure dome membrane leak had occurred during a patient treatment.The photographs show that the leak occurred from the system pressure dome.Further examination showed the diaphragm of the system pressure dome was partially unseated and blood had leaked through the gap between the diaphragm and the body of the pressure dome.If the pressure dome is not properly attached to its pressure sensor, because one of its latches isn't secured in the circumferential groove around the sensor, the diaphragm of the pressure dome can become unseated when system pressure is high.The root cause of the pressure dome membrane leak is due to the system pressure dome diaphragm becoming unseated.The root cause of the system pressure dome diaphragm becoming unseated most likely occurred during installation of the pressure dome by the end user.No manufacturing related defects were identified during this investigation.No further action is required at this time.This investigation is now 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 reported they received an alarm #16: collect pressure alarm and noticed blood leaking from the collect pressure dome.The blood leak was observed after approximately 170 ml of whole blood had been processed.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was in stable condition.The customer has returned the smart card and photographs for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster, nj
• 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
• MDR Report Key: 9884364
• MDR Text Key: 198753843
• Report Number: 2523595-2020-00045
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H361(17)211001
• 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: 03/26/2020

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: 10/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• 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
• Patient Age: 66 YR