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

Catalog Number CLXECP

Device Problem Gas/Air Leak (2946)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction photoactivation module 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 j261 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j261 shows no trends.Trends were reviewed for complaint categories, alarm #53: return line air detected and photoactivation module leak.No trends were detected for these complaint categories.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 and photographs 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 photoactivation module leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported at the end of the ecp treatment they received an alarm #53: return line air detected and noticed a leak coming from the photoactivation chamber.The customer disconnected the patient and reported the patient was in stable condition.The customer returned the kit and photographs for investigation.

Manufacturer Narrative

The complaint kit, smart card, and photographs were provided for investigation.Review of the data recorded on the smart card verified the prime phase was successfully completed and the ecp treatment proceeded through the photoactivation phase of the procedure.After photoactivation was completed, multiple alarm #48: treatment bag - air detected warnings occurred.The operator aborted the treatment after the alarms were received.There were no alarm #53: return line air detected warnings as reported by the customer.The customer provided photographs verify a crack in the photoactivation module that runs along one of the channels in the module.Examination of the received kit confirmed the crack in the module, running along the weld between the channels in the center of the module.Further inspection of the module showed the weld had failed and fluid leaked internally between the channels.The photoactivation module was pressure tested and verified a leak at the site of the crack.A material trace of the illumination plates used to build lot j261 did not find any non-conformances.The device history record (dhr) review did not result in any related non-conformances and this kit lot passed all lot release testing.The root cause for photoactivation module leak was most likely due to the weld failure between fluid channels within the photoactivation module.The cause of the weld failure 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) 2021.

• 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
• MDR Report Key: 12111440
• MDR Text Key: 265677028
• Report Number: 2523595-2021-00059
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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: 11/01/2022
• Device Catalogue Number: CLXECP
• Device Lot Number: J261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 46