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 02/23/2023

Event Type  malfunction  

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 approximately 400mls of whole blood was 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 returned the kit for evaluation.

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 l347 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l347 shows no trends.Trends were reviewed for complaint category tubing leak.No trend was 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).Ns 24-mar-2023.

Manufacturer Narrative

The complaint kit was returned for evaluation.The saline drip chamber with the saline bag still attached was the only part of the kit returned for evaluation.The saline drip chamber was pressure tested to check for leaks and a leak was verified coming from the bond between the saline spike chamber and clear tubing.Further inspection of the returned kit showed that the clear tubing was fully inserted into the spike chamber port; however, there is a lack of solvent in the port that connects the clear tubing to the spike chamber.A material trace of the spike chamber with a vented guard used to manufacture lot l347 did not find any non-conformances.A device history record (dhr) review did not result in any related non-conformances.This lot passed all lot release testing.The tubing leak from the bond port indicates the solvent bond was insufficient.The root cause of the tubing leak is most likely due to manufacturing operator error during the tube bonding operation.Retraining was completed with all bonding operators at the manufacturing facility (b)(60 -2023.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: 16609855
• MDR Text Key: 312318100
• Report Number: 3013428851-2023-00011
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)L347(17)240801
• 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: 05/23/2023

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 Catalogue Number: CLXUSA
• Device Lot Number: L347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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