MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

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

Event Date 06/15/2018

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 g219 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g219 for the reported issue shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber) and drive tube leak/break.No trends were detected for each complaint category.Photographs were provided by the customer for evaluation.A review of the photographs show the drive tube and centrifuge bowl assembly are still installed on the cellex instrument.The drive tube appears damaged above the upper drive tube bearing stop.The photograph does not provide visual evidence that fluid leaked from the damaged portion of the drive tube.However, review of the second photograph of the instrument's display verifies that a leak in the centrifuge chamber occurred during the treatment as an alarm #7: blood leak (centrifuge chamber) had occurred.A device history record review did not identify any related nonconformances and this kit lot had passed all lot release testing.A material trace of the drive tubes used to build lot g219 did not find any non-conformances.The root cause of the reported drive tube leak/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).

Event Description

The customer called to report a drive tube leak/break during the treatment procedure.The customer stated approximately 60 ml of whole blood was processed when they received an alarm #7: blood leak (centrifuge chamber) alarm.The customer stated the drive tube and centrifuge bowl components were still in place.The customer reported only saline had leaked out from the drive tube component, right above the upper drive tube bearing retainer clip.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable and started treatment after on another instrument.The customer has returned photographs for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• 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 07921
• MDR Report Key: 7675367
• MDR Text Key: 114031748
• Report Number: 2523595-2018-00109
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: G219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• 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: 64 YR
• Patient Weight: 66