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

Model Number CLXUSA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/24/2020

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 j311 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j311 shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.The complaint kit with smart card was returned for investigation.A review of the data recorded on the smart card data showed that the treatment proceeded until an alarm #52: collect line air detected was received after 274 ml of whole blood had been processed.Visual inspection of the returned kit found a scuff on the return pump tubing segment.The tubing segment was pressure tested to check for leaks and a leak was verified at the site of the scuff.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 inadvertently rubbed against the pump head during installation by the end user.All cellex kits are leak tested prior to packaging.A leak of this nature would have been detected during in-process testing; therefore, it is unlikely the tubing damage was present at the time of manufacture.The root cause of the damage to the pump loop tubing was most likely caused during installation 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.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported approximately 275 ml of whole blood was processed at the time the leak occurred.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was stable.The customer returned the kit with smart card 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: 10440539
• MDR Text Key: 209846521
• Report Number: 2523595-2020-00097
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J311(17)220201
• 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: 08/22/2020

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: 02/01/2022
• Device Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Device Lot Number: J311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• 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: 35 YR