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

Catalog Number CLXUSA

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 01/05/2021

Event Type  malfunction  

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 j348 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j348 shows no trends.Trends were reviewed for complaint category, pressure dome membrane leak.No trends were detected for this complaint category.The kit with smart card was returned for evaluation.Review of the smart card data showed blood collection began in single needle mode.The treatment proceeded through the purging air phase of the procedure until a system pressure alarm occurred after 204 ml of whole blood had been processed.The pump tubing organizer (pto) and the system pressure dome was the only kit components returned for evaluation.Examination of the pressure dome found the diaphragm was partially unseated from the body of the pressure dome.The pressure dome was inspected and found no obvious manufacturing issues.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.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 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.04-feb-2021.

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 at approximately 204 ml of whole blood processed the system pressure dome detached and resulted in a blood leak.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was stable and would start a new treatment with a new kit.The customer returned the kit and smart card for investigation.

• 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: 11282983
• MDR Text Key: 264304751
• Report Number: 2523595-2021-00012
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J348(17)220601
• 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: 02/04/2021

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: 06/01/2022
• Device Catalogue Number: CLXUSA
• Device Lot Number: J348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2020
• 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 Age: 63 YR
• Patient Weight: 80