MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

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

Event Date 10/04/2019

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 h104 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot h104 shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.Visual inspection of the photographs confirms a small pool of blood next to the recirculation pump head and a scrape/cut in the recirculation pump loop tubing.The damage to the tubing is at the location where there is an edge on the instrument pump head.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 rubbed against the pump head during installation by the end user.If the pump loop is forcefully rubbed against the pump head during installation of the kit, it could potentially result in scraping and/or cutting of the tubing loop as the pump head rotates.It is unlikely the return pump tubing segment was damaged prior to product release as an in-process leak test is performed on all cellex kits prior to packaging.A material trace of the tubing used to manufacture lot h104 showed no non-conformance.A device history record review did not result in any related non-conformances.This lot passed all lot release testing.The investigation determined that the root cause of the tubing leak was most likely caused by damage that occurred during installation of the pump loop.The cause for the alarm #1: air detected is due to the damaged tubing.No manufacturing related defects were identified through this investigation.No further action is required at this time.This investigation is now complete.Mc: (b)(4).S.D.A.(b)(6) 2019.

Event Description

The customer contacted mallinckrodt to report that they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated that they received an alarm #1: air detected warning during photoactivation and they observed air in the treatment bag.Customer stated that the treated cells were reinfused and that the patient is stable.The customer returned photographs 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: 9286316
• MDR Text Key: 220044594
• Report Number: 2523595-2019-00132
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2019

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: 01/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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: 10 YR
• Patient Weight: 23