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

Catalog Number CLXECP

Device Problem Connection Problem (2900)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.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 k103 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k103 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.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).

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") after an extracorporeal photopheresis (ecp) treatment was completed.The customer reported when they were unloading the kit they observed a blood leak on the drive tube where it is inserted into the drive tube clamp.The customer reported the patient was in stable condition.The customer returned the kit for investigation.

Manufacturer Narrative

Correction: d9: device available for evaluation?: no.H3: device evaluated by manufacturer?: not returned to manufacturer.The complaint kit was not received for evaluation.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.A review of all drive tube leak/break complaints documented in mallinckrodt's electronic database did not identify any similar occurrences for kit lot k103.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6) 2022.

Manufacturer Narrative

The complaint kit was returned for investigation.Examination of the returned drive tube verified the reported drive tube leak as dried blood was found on the lower end of the drive tube at the location of the tri-connector.The drive tube was pressure tested to check for leaks and a leak was verified at the bond between the lower end of the drive tube and the tri-connector.A material trace of the drive tube used to manufacture kit lot k103 found one non-conformance.The non-conformance was associated with a leak identified at the drive tube and tri-connector joint during finished product release testing for a different kit lot.A device history record (dhr) review did not result in any related non-conformances and this kit lot passed all lot release testing.A review of all drive tube leaks documented in mallinckrodt's electronic complaint database did not identify any similar occurrences for kit lot k103.The root cause of the drive tube leak was most likely due to a weak solvent bond or due to a sink in the tri-connector bond socket; however, a definitive root cause could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4), p.T.(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: 12704127
• MDR Text Key: 282927860
• Report Number: 2523595-2021-00088
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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,Followup
• Report Date: 09/08/2022

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: 01/01/2023
• Device Catalogue Number: CLXECP
• Device Lot Number: K103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 02/23/2022; 08/11/2022
• Supplement Dates FDA Received: 02/23/2022; 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• 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