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

Catalog Number CLXUSA

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Priming Problem (4040); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

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 l328 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l328 shows no trends.Trends were reviewed for complaint categories, alarm #48: treatment bag - air detected, tubing leak and clot observed.No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned photographs and smart card is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).N.S.28-feb-2023.

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 they received an alarm #48: treatment bag - air detected during prime, that was resolved and the treatment continued.The customer reported after the photoactivation phase of the treatment they observed air and blood clots in the treatment bag.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The customer stated they attempted to remove the recirculation pump tubing and it began to leak.The customer reported approximately 1500ml of whole blood was processed at the time the leak was observed.The customer reported the patient was in stable condition.The customer will return photographs and the smart card for evaluation.

Manufacturer Narrative

Photographs were provided by the customer for evaluation.The complaint kit and smart card were not returned.The smart card was not returned, therefore the reported alarm #48: treatment bag - air detected alarm could not be verified.Review of the provided photographs show the pump tubing organizer (pto) installed on the pump deck.There are no blood leaks visible on the pump deck or coming from any of the tubing.Air is visible in the tubing lines.An additional photograph shows the treatment bag component of the kit.The treatment bag is filled with air as reported by the customer.The customer report of blood clots in the treatment bag could not be verified based on the photographs provided.Section 2-9 of the cellex operators manual (1470493 rev 6) for use with software 5.4 on anticoagulant states "caution: individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment.The physician should review the patient's medical condition, medications and platelet count at the time of treatment and use clinical judgement to establish the optimal heparin dosage for each patient." the customer complaint was not verified based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).N.S.(b)(6) 2023.

• 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: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 16456425
• MDR Text Key: 310532796
• Report Number: 3013428851-2023-00009
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)L328(17)240401
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 03/23/2023

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: 04/01/2024
• Device Catalogue Number: CLXUSA
• Device Lot Number: L328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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 Sex: Female