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

Catalog Number CLXUSA

Device Problems Fluid/Blood Leak (1250); Protective Measures Problem (3015)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube 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 k315 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k315 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak? (cent chamber) and drive tube leak/break.No trends were detected for these complaint categories.A photograph was provided by the customer for evaluation.The complaint kit and smart card were not returned.The customer provided photograph verifies the drive tube had broken between the upper and lower drive tube bearing stops.The lower drive tube is visibly secured in the lower drive tube clamp; however, the upper drive tube is no longer secured in the upper drive tube clamp.The centrifuge bowl appears to be appropriately locked in the instrument's bowl holder.The broken ends of the drive tube are not visible for further inspection.A material trace of the drive tube assembly and its components used to build lot k315 did not find any related non-conformances.A device history record review for kit lot k315 did not identify any related non-conformances, deviations or equipment maintenance events.This kit lot had passed all lot release testing.A known root cause for this failure mode is an operator misload of the drive tube bearing into the instrument's drive tube clamp.However, a definitive root cause for the drive tube break associated with this incident could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during and extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #7: blood leak? (cent chamber) during the procedure after approximately 163ml of whole blood had been processed.The customer stopped the treatment and noticed the drive tube bearing was not secured in the upper drive tube bearing retainer.The customer reported there was a blood leak in the centrifuge chamber.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 photographs 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 ; 9082351030
• MDR Report Key: 12565162
• MDR Text Key: 275281385
• Report Number: 2523595-2021-00081
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)K315(17)230301
• 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: 10/01/2021

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: 03/01/2023
• Device Catalogue Number: CLXUSA
• Device Lot Number: K315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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