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

Catalog Number CLXUSA

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a centrifuge bowl leak/break with their cellex photopheresis kit during an extracorporeal photopheresis (ecp) treatment.The customer reported the centrifuge bowl broke after 400 ml of whole blood had been processed.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The customer reported the patient was in stable condition.The customer returned the kit and smart card for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl 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 k372 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k372 shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break and alarm #7: blood leak? (cent chamber).No trends were detected for these complaint categories.The product monitoring data is within control limits.The complaint kit and smart card were returned for evaluation.A review of the data on the smart card verified the occurrence of an alarm #7: blood leak (centrifuge chamber) alarm after 95ml of whole blood had been processed.An incomplete device was returned for investigation.The centrifuge bowl was not returned.The pump tubing organizer (pto) was the only kit component returned for evaluation.Inspection of the returned pto found no obvious manufacturing issues.The reported alarm #7: blood leak (centrifuge chamber) alarm was verified based on the smart card data and is consistent with a leak in the centrifuge chamber such as a centrifuge bowl break.However, the centrifuge bowl break could not be verified based on the available information.The root cause for the reported centrifuge bowl break could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4) (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: 14800893
• MDR Text Key: 301284258
• Report Number: 3013428851-2022-00048
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)K372(17)231101
• 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: 06/24/2022

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: 11/01/2023
• Device Catalogue Number: CLXUSA
• Device Lot Number: K372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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: Female