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

Model Number CLXUSA

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

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

Event Date 10/13/2020

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 j329 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j329 shows no trends.Trends were reviewed for complaint categories, pressure dome membrane leak and alarm #18: system pressure.No trends were detected for these complaint categories.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Section 4-17 of the cellex operators manual (1460415rev 5.0) on installing the three pressure domes states "partial pressure dome attachment may provide pressure readings, but as pressure increase, the internal membrane may separate from the pressure dome.Fluid leaks may occur resulting in loss of sterility, blood leaks, and possible blood loss to the patient".The root cause of the pressure dome membrane leak was most likely due to use error by the end user.The customer stated they believed the pressure dome was not installed securely enough and there is nothing wrong with the kit.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(4).P.T.10-nov-2020.

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 approximately 950 ml of whole blood was processed at the time the pressure dome leak occurred.The customer stated they received an alarm #18: system pressure alarm and observed a blood leak from the return pressure dome.The customer stated they believe the pressure dome was not installed securely.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 did not return the product 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: 10819619
• MDR Text Key: 242398963
• Report Number: 2523595-2020-00119
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J329(17)220401
• Combination Product (y/n): Y
• 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: 11/10/2020

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: 04/01/2022
• Device Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Device Lot Number: J329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• 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: 54 YR
• Patient Weight: 65