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

Catalog Number CLXECP

Device Problem Leak/Splash (1354)

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

Event Date 08/04/2022

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 k257 was conducted.There were no non-conformances associated with this lot.A review of kit lot k257 identified an increase in complaints for this kit lot.This assessment is based on the information available at the time of the investigation.At the time of this report, the complaint kit has not yet been received.A supplemental report will be filed when the analysis is complete.(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 the leak was coming from the saline tubing.The customer reported the ecp treatment was completed and blood was returned to the patient.The customer reported the patient was in stable condition.The customer provided a photograph and will return the kit for investigation.

Manufacturer Narrative

Review of the provided photograph verifies the reported tubing leak as there is a cut in the tubing leading up to the saline drip chamber.Capa-2022-0120 was initiated to investigate the increase in tubing leak complaints observed for kit lot k257.The tubing leak occurred at the saline spike chamber and tubing bond interface.A review of the 50/50 solvent used to adhere the saline spike to the clear tubing was performed.A material trace of the spike chamber, clear tubing and 50/50 solvent used to build lot k257 did not find any non-conformances.The solvent used to adhere the saline spike and clear tubing is also used for other bonds.All other bonds on the returned samples were reviewed and inspected.No issues were observed with the other bonds.Three retains from kit lot k257 were pressure tested to check for leaks and no leaks were observed.During incoming inspection spike chambers and clear tubing are sampled and inspected for any obvious damage.The inner diameter of the port at the base of the spike chamber is measured along with the length of the spikes at the top of the spike chamber to ensure they are within specification.Clear tubing is inspected, and a sample of the tubing outer and inner diameter are measured to verify they are within specification.No issues were found at incoming inspection of the spike chambers and clear tubing.Manufacturing bonding operators follow work instruction operation 60a step 7 to bond the clear tubing to the spike chamber using a 50/50 double solvent dip.Operators are to hold the bond for approximately 5 seconds to ensure the tubing does not push back out of the bond socket.The tubing leak from the bond port indicates the solvent bond joint was insufficient.The root cause of the tubing leak is most likely due to manufacturing operator error during the tube bonding process.Awareness training was completed with manufacturing operators on operation 60a of work instructions to ensure the bond between the clear tubing and spike chamber is sufficient.A quality alert was posted for manufacturing operators as a result of this complaint.Additional corrective actions and/or process improvements may be identified and implemented via capa-2022-0120.No further action is required at this time.Comp-(b)(4).H.M.(b)(6) 2022.

• 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: 15331746
• MDR Text Key: 305372963
• Report Number: 3013428851-2022-00063
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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,Followup
• Report Date: 12/08/2022

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: 12/01/2023
• Device Catalogue Number: CLXECP
• Device Lot Number: K257
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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