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

Model Number NOT APPLICABLE

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

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

Event Date 11/22/2019

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 h317 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h317 for the reported issue shows no trends.Trends were reviewed for complaint categories, pressure dome membrane leak and alarm #18: system pressure.No trends were detected for each complaint category.Photographs were provided by the customer for evaluation.Examination of the provided photographs verify the pressure dome membrane leak as blood is seen on the instrument pump deck.The photographs show the system pressure dome is detached from the system pressure transducer.In addition, the photographs show that the pressure dome membrane is partially unseated from the pressure dome housing.If a pressure dome is not properly seated into the circumferential groove of the cellex pressure transducer, fluid pressure could potentially force the pressure dome to lift at the membrane and result in a leak during treatment.A material trace of the pressure dome housing assembly and its components used to build lot h317 did not find any non-conformances.A device history record review did not identify any related non-conformances, and this kit lot had passed all lot release testing.The alarm #18: system pressure alarm could not be verified based on the available information; however, the alarm is consistent with a pressure dome detaching from the pressure sensor.The cause of the pressure dome membrane leak is most likely the pressure dome becoming detached from the pressure sensor.However, a definitive root cause for the system pressure dome becoming detached from the system pressure transducer could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report 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 #18: system pressure alarm and observed blood leaking from the system pressure dome.The customer reported the kit's system pressure dome was not seated all the way down on the cellex instrument's system pressure transducer.The customer reported approximately 200 ml of whole blood was processed when the leak was observed.The customer aborted the ecp treatment and did not return residual blood to the patient.The customer stated the patient was in stable condition.The customer discarded the kit; however, photographs were provided for evaluation.

• 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: 9489756
• MDR Text Key: 198760338
• Report Number: 2523595-2019-00149
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H317(17)210301
• 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: 12/18/2019

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: 03/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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
• Patient Age: 44 YR