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

Catalog Number CLXECP

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/17/2023

Event Type  malfunction  

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 they observed a blood leak coming from the pto during the procedure.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 returned the kit and photographs for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction 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 m110 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot m110 shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for this complaint category.At the time of this report, the analysis of the kit and photographs is still in progress.A final report will be filed when the analysis is complete.(b)(4).H.M.(b)(6) 2023.

Manufacturer Narrative

The complaint kit, photographs and smart card data were returned for investigation.A review of the data recorded on the smart card showed the treatment proceeded to the blood collection phase of the procedure, and multiple alarm #16: collect pressure warnings occurred during before the operator aborted the procedure.The treatment was aborted after approximately 205 ml of whole blood had been processed.Examination of the customer provided photographs confirm the report of a blood leak in the pump tubing organizer (pto).Examination of the returned kit verified a blood leak inside the pto.The pto was pressure tested to check for leaks and a leak was verified coming from the bond between the y-connector and the yellow stripe tubing.The tubing leak from the bond port indicates the solvent bond joint was insufficient.A material trace of the components used to build lot m110 found no related non-conformances.The device history record (dhr) review did not result in any related non-conformances.This kit lot passed all lot release testing.The root cause for the pto leak is most likely due to manufacturing operator error during the tube bonding operation.Retraining has been completed with all bonding operators at the manufacturing facility.No further action is required at this time.This investigation is now complete.(b)(4).H.M.(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; i.d.a. business park; castlerea roscommon, ; EI
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 18397668
• MDR Text Key: 331943264
• Report Number: 3013428851-2023-00081
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: HR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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: CLXECP
• Device Lot Number: M110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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