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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pump tubing organizer (pto) 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 j212 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot j212 shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.The complaint kit with smart card was not returned.A review of the photographs verify a blood leak coming from the pump tubing organizer (pto) installed on the cellex instrument pump deck.The leak appears to be coming from inside the pto; however, the exact location of the leak could not be determined based on the photographs provided.A device history record (dhr) review did not result in any related non-conformance's and this kit lot passed all lot release testing.The root cause for the pto leak could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).P.T.(b)(6) 2020.

Event Description

The customer contacted mallinckrodt to report they experienced a pump tubing organizer (pto) leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported a blood leak was observed in the pump tubing organizer during the buffy coat collection phase of the procedure.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The patient was reported to be in good condition.The customer discarded the kit and 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: 10658330
• MDR Text Key: 212776626
• Report Number: 2523595-2020-00113
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/09/2020

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: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: J212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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: 63