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

Catalog Number CLXUSA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/11/2023

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 m301 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot m301 shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.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 kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).H.M.07 nov 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 a leak from the tubing connected to the saline spike.The customer reported approximately 500 ml of whole blood had been processed at the time the leak was observed.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The customer reported the patient was in stable condition.The customer will return the kit for investigation.

Manufacturer Narrative

The complaint kit was returned for evaluation.The smart card was not returned.The kit was received intact; however, the saline spike chamber was separated from the rest of the kit.The saline spike chamber was pressure tested to check for leaks and a leak was verified coming from the bond between the saline spike chamber and tubing.Further examination of the saline spike chamber found the tubing was fully inserted into the spike chamber port; however, there is a lack of solvent on the tubing.The tubing leak from the bond port indicated the solvent bond joint was insufficient.A material trace of the spike chamber w/ vented guard used to build lot m301 did not find any non-conformances.The device history record (dhr) review did not result in any related non-conformances.This lot passed all lot release testing.The most likely root cause for the tubing leak is due to manufacturing operator error during the tube bonding operation.Retraining was completed with all bonding operators on 09 jan 2024.No further action is required at this time.This investigation is now complete.(b)(4); (b)(6) 2024.

• 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): HARMAC MEDICAL PRODUCTS, INC.; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 18088161
• MDR Text Key: 327641157
• Report Number: 3013428851-2023-00072
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)M301(17)250101
• 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: 01/18/2024

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 Catalogue Number: CLXUSA
• Device Lot Number: M301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2023
• 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: 50 YR
• Patient Sex: Male