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

Model Number NOT APPLICABLE

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

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 g307 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g307 for the reported issue shows no trends.Trends were reviewed for complaint categories, drive tube leak/break and alarm #7: blood leak (centrifuge chamber).No trends were detected for each complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a drive tube leak/break during the treatment procedure.The customer stated they received an alarm #7: blood leak (centrifuge chamber) alarm and stopped the treatment.The customer stated after stopping the treatment they inspected the centrifuge chamber where they noticed a leak coming from the drive tube component of the kit.The customer stated the leak appeared to be coming from the location on the drive tube where it is secured to the bearing retainer clip.The customer stated the patient was disconnected after the leak occurred and the treatment was aborted with no blood returned to the patient.The customer stated the patient started treatment on another instrument after.The customer stated the patient was stable.The customer has returned photographs for investigation.

Manufacturer Narrative

Photographs were provided by the customer for evaluation.A review of the photographs show a fine spray of blood in a narrow band around the circumference of the centrifuge chamber wall.The blood spray is also visible on the drive tube which suggests the centrifuge bowl could be the source of the blood leak.However, the origin of the blood leak cannot be confirmed based on the photographs provided.The reported blood leak is confirmed based on the photographs.A material trace of the drive tube assembly, outer bowl cover and outer bowl used to build lot g307 found no related non-conformances.A device history record review did not identify any related non-conformances, and this kit lot had passed all lot release testing.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).(b)(6) 2018.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7644028
• MDR Text Key: 112886793
• Report Number: 2523595-2018-00108
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G307(17)200101
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G307
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR