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 11/10/2021

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a pressure dome membrane leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed a blood leak at the system pressure dome when approximately 160 ml of whole blood was processed.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was in stable condition.The customer returned the complaint kit, smart card, and a photograph for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome membrane 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 k328 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k328 shows no trends.Trends were reviewed for complaint category, pressure dome membrane leak.No trends were detected for this complaint category.The complaint kit, smart card, and a photograph was returned for investigation.A review of the data recorded on the returned smart card shows that the prime was completed, and blood collection began in single needle mode.As blood collection started the operator received system pressure alarms and an ac pump error warning.The operator aborted the treatment after 161 ml of whole blood had been processed.Review of the provided photograph verifies the pressure dome membrane leak as blood is seen leaking at the system pressure sensor.The diaphragm of the system pressure dome is partially unseated from the body of the pressure dome.Examination of the returned kit confirmed the diaphragm was partially unseated from the body of the system pressure dome.The pressure dome was inspected and found no obvious manufacturing issues or tears in the diaphragm.The diaphragm was put back into place on the body of the pressure dome and was pressure tested to check for leaks.Pressure testing of the pressure dome did not result in any leaks.The pressure dome latched into the circumferential groove around the sensor as expected.If a pressure dome is not properly attached to its pressure sensor because one of its latches isn't secured in the circumferential groove around the sensor, the diaphragm of the pressure dome will have room to move and can become unseated when pressure is increased.All cellex kits are leak tested prior to packaging.A leak of this nature would have been detected during in-process testing; therefore, it is unlikely the pressure dome leaked at the time of manufacture.The cause of the reported leak was most likely due to the diaphragm becoming unseated from the body of the pressure dome.The root cause of the pressure dome leak was most likely due to the pressure dome not being secured to the pressure sensor during installation of the pressure dome by the end user.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
• 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: 12967876
• MDR Text Key: 285942545
• Report Number: 2523595-2021-00102
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)K328(17)230401
• 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
• Report Date: 12/09/2021

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: 04/01/2023
• Device Catalogue Number: CLXUSA
• Device Lot Number: K328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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
• Patient Sex: Male