MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CLXECP

Device Problem Leak/Splash (1354)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Chills (2191); Dizziness (2194)

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction bag 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 k215 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k215 shows no trends.Trends were reviewed for complaint category, bag leak.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.The complaint kit and smart card were not returned.The customer provided photographs show the needle-free port on the treatment bag.There are no signs of damage to the port and no blood residue is seen in the photograph.An additional photograph shows the kit installed on the cellex instrument.The customer reported drops of blood on the floor, below where the treatment bag is hung.The provided photographs could not confirm any blood leaks on the floor or from any of the kit components.A material trace of the needle-free port and pvc film used to build kit lot k215 did not find any non-conformances.The device history record (dhr) review did not result in any related non-conformances and this kit lot passed all lot release testing.An inspection was performed on 9 master retains for finished kits with the same needle-free port lot number.Twenty-seven (27) needle-free ports from the retain kits were pressure tested to check for leaks, no leaks were identified and no issues with the needle-free ports were found.The customer complaint could not be verified based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a bag leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they injected methoxsalen into the treatment bag and then observed a blood leak from the needle-free injection port on the treatment bag.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer complaint was assessed and determined that no serious event had occurred.The customer discarded the kit and returned photographs for evaluation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• 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 ; shelbourne building; 53 frontage rd suite 300; hampton, NJ 08827
• MDR Report Key: 12756352
• MDR Text Key: 286075753
• Report Number: 2523595-2021-00096
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• 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: 11/04/2021

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: 03/01/2023
• Device Catalogue Number: CLXECP
• Device Lot Number: K215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 62 KG