MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

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

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 h355 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h355 shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.The customer provided photographs for investigation.Examination of the photographs verifies the tubing leak at the return pump tubing segment.The photographs show a cut in the return pump tubing segment.A material trace of the blue stripe tubing used to build lot h355 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.It is unlikely that the tubing segment was damaged prior to product release as an in-process leak test is performed on all kits prior to packaging.The size, shape, and location of the observed damage on the pump loop is consistent with damage that occurs if the pump loop tubing is inadvertently rubbed against the pump head during installation or removal by the end user.The root cause of the tubing leak is most likely the damage to the pump tubing segment that occurred during installation or removal of the pump loop by the end user.No manufacturing related defects were confirmed during the evaluation.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 tubing leak with their cellex photopheresis kit ("kit") after an extracorporeal photopheresis (ecp) treatment was completed.The customer reported that the treatment was successfully completed and when unloading the pump tubing segment from the pump head the tubing slit open and leaked.The patient had been disconnected from the cellex instrument at the time the leak was observed.The customer returned 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: 10339218
• MDR Text Key: 208326365
• Report Number: 2523595-2020-00088
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H355(17)210901
• 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: 07/29/2020

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: 09/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• 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