MAUDE Adverse Event Report: MALLINCKRODT HOSPITAL PRODUCTS INC. CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CLXECP

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review for kit lot l245 was conducted.There were no non conformances associated with this lot.This lot met all release requirements.A review of kit lot l245 shows no trends.Trends were reviewed for complaint category, bag 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 kit and smart card is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).(b)(6).

Event Description

The customer contacted mallinckrodt to report they experienced a bag leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they found that the treatment bag was leaking when attempting to inject the methoxsalen.The treatment was completed, and blood was returned to the patient.The customer reported the patient was in stable condition.The customer returned the kit and smart card for investigation.

Manufacturer Narrative

The complaint kit and smart card were returned for investigation.A review of the data on the smart card showed that the treatment was completed without the occurrence of any alarms, system errors, or warnings.The kit was returned in double needle mode and the treatment bag had been cut away from the rest of the kit.A syringe was attached to the needle free injection port on the treatment bag and liquid was able to be pumped into the treatment bag without issue.The report of an injection port issue was not confirmed as water was successfully injected into the bag.The treatment bag was pressure tested to check for leaks and a leak was verified coming from the needle free port on the treatment bag.The customer reported then used a needle to inject methoxsalen.The leak coming from the needle free injection port was most likely due to the damage caused by the customer using a needle to inject methoxsalen into the needle free injection port.A material trace of the needle free ports used to build lot l245 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 root cause of the bag leak was most likely due to the customer using a needle to inject methoxsalen into the needle free injection port.No manufacturing related defects were identified during the investigation.No further action is required at this time.(b)(4) h.M.20 jun 2023.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT HOSPITAL PRODUCTS INC.; 440 route 22 east; suite 302; bridgewater NJ 08807
• 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: 16637210
• MDR Text Key: 313195122
• Report Number: 3013428851-2023-00013
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 06/20/2023

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: CLXECP
• Device Lot Number: L245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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