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

Catalog Number CLXUSA

Device Problems Break (1069); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.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 j337 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j337 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.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.The customer stated they noticed the drive tube was not properly installed in its retainer, and admitted it was their fault for not installing it properly.Section 4-9 of the cellex operators manual (1460415rev 5.0) on installing the therakos cellex photopheresis procedural kit states "caution: damage to the centrifuge bowl or drive tube could result in further damage to the instrument, loss of treatment, and extracorporeal blood loss.During installation, do not excessively bend, kink, or damage the drive tube, bearings, or centrifuge bowl." section 4-12 states "caution: verify the drive tube bearing is correctly aligned in the bearing retainer clip and the bearing retainer clip latch is closed." the root cause of the drive tube break was most likely caused by not securing the drive tube bearing into the retainer clip during installation of the drive tube 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.Comp (b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported approximately 500 to 600 ml of whole blood was processed at the time the break occurred.The customer stated they noticed the drive tube was not properly installed into its retainer clip.The customer admitted it was their fault for not installing the drive tube properly.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: 10935777
• MDR Text Key: 234411827
• Report Number: 2523595-2020-00128
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J337(17)220501
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: CLXUSA
• Device Lot Number: J337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• 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: 50 YR
• Patient Weight: 64