MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2020

Event Type  malfunction  

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 h127 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h127 shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break and system error 130.No trends were detected for these complaint categories.The customer returned photographs for investigation.Evaluation of the customer provided photographs verifies that the centrifuge bowl broke as blood splatter is seen on the centrifuge chamber walls and the bowl is in pieces at the bottom of the centrifuge chamber.The centrifuge bowl had dislodged from the bowl holder and the drive tube had broken apart from the centrifuge bowl.The centrifuge leak detection strip is damaged.A material trace of the bowl assembly and its components used to build lot h127 found no related non-conformances.A device history record review of kit lot h127 did not identify any related non-conformances and this kit lot had passed all lot release testing.A cause for a system error 130 is a damaged centrifuge leak detection strip.A known cause of a damaged centrifuge leak detection strip is a misload of the drive tube bearing into the drive tube retainer clip by the end user.If the drive tube bearing is not securely loaded into its retainer clip the centripetal force would cause the bearing to move to the center of the drive tube and eventually impact the centrifuge chamber wall.However, a definitive root cause for the centrifuge bowl break could not be determined from the information provided.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report that they experienced a centrifuge bowl leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated that the break occurred approximately 10 minutes into the treatment.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The patient was reported to be in stable condition.The customer indicated that a system error 130 occurred.The customer returned photographs for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster, nj
• 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 ; 1425 us route 206; bedminster, nj
• MDR Report Key: 10430019
• MDR Text Key: 205688947
• Report Number: 2523595-2020-00098
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/20/2020

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: 05/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2019
• 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