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

Catalog Number CLXUSA

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)

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

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 k338 was conducted.There were no non-conformances related to this lot.This lot met all release requirements.A review of kit lot k338 shows no trends.Trends were reviewed for complaint categories, alarm #1: air detected and tubing leak.No trends were detected for these complaint categories.The complaint kit and smart card were returned for evaluation.A review of the data on the smart card verified the occurrence of multiple alarm #1: air detected warnings during the treatment.Examination of the received kit found no obvious manufacturing issues or evidence of a leak.The customer reported seeing a fluid leak on the floor underneath the anticoagulant (ac) bag.The ac bag and respective ac drip chamber were leak tested and no leaks were identified.The same test was repeated with the saline bag and saline drip chamber and no leaks were found.A leak test was performed on the collect tubing line and ac tubing line and no leaks were found.Lastly, each of the pump tubing segments and the collect tubing line were pressure tested and no leaks were identified.An examination of the returned kit did not verify any leaks.The customer complaint was not verified.No manufacturing related defects were identified during this investigation.No further action is required at this time.This investigation is now complete.(b)(4).H.M.23-jun-2022.

Event Description

The customer contacted mallinckrodt to report they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported an alarm #1: air detected alarm during treatment after 1149ml of whole blood had been processed.The customer reported a leak coming from the kit tubing.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 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: 14789469
• MDR Text Key: 303392050
• Report Number: 3013428851-2022-00046
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)K338(17)230601
• 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: 06/23/2022

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: 06/01/2023
• Device Catalogue Number: CLXUSA
• Device Lot Number: K338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 76 KG