MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); Bent (1059); Fluid/Blood Leak (1250); Material Fragmentation (1261)

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

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e344 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber) and centrifuge bowl leak/break.No trends were detected for these complaint categories.However an issue review was opened for complaint category, centrifuge bowl leak/break.This assessment is based on information available at the time of the investigation.The analysis of the returned kit photos is still in progress.A supplemental report will be filed when the analysis of the kit photos is complete.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a centrifuge bowl leak/break during the purging air phase of a treatment.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the patient did not require any medical intervention, and they planned to start a new treatment for this patient on a different instrument.The customer stated that when the centrifuge bowl leak/break occurred, "there was not a stop button".The customer reported that they did not remember hearing or getting an alarm.The customer stated that they turned off the power to the instrument after the centrifuge bowl leak/break, and when they turned the power back on, they received an alarm #7: blood leak (centrifuge alarm).The customer reported that there was at least a three inch section of the fluid leak detector strip that was damaged.The customer stated that the centrifuge bowl was shattered and no part of the bowl remained attached to the bowl holder.The customer reported that the lower bearing of the drive tube was still installed, but the lower bearing clip was bent.The customer stated that the upper bearing of the drive tube was no longer attached, but the customer did not note if the upper bearing clip was damaged.Service was requested.On november 2, 2016, the customer reported that plastic pieces from the shattered centrifuge bowl, as large as 1x 1 inch, escaped from the centrifuge door.The customer stated that one piece landed on the floor.The customer reported that the bottom drive tube bearing clip appeared to be slightly bent and the fluid leak detector strip was shredded.The customer stated that the blood leaked onto the instrument's pump deck.The customer reported that two operators confirmed the kit's loading prior to priming the kit, and both of these operators had attended recent training.On november 8, 2016, the decision was made to exchange this instrument as a result this instrument will not be serviced.This instrument will be returned for investigation.Photos of the kit were submitted for investigation.The instrument based reported will be submitted under medwatch 2523595-2016-00269.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the centrifuge bowl leak/break.However, the cause for the centrifuge bowl leak/break could not be determined based on the information provided.A review of the device history record for this kit lot did not identify any related nonconformances.A material trace of the centrifuge bowl assembly and its components used to build this kit lot also found no nonconformances.A capa was initiated at the manufacturing site in order to further investigate the root cause and associated corrective actions for centrifuge bowl leak/breaks.This investigation is now complete.Correction: manufacturing date: 08/25/2016.(b)(4).Device not returned to manufacturer.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6139807
• MDR Text Key: 61602792
• Report Number: 2523595-2016-00268
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E344(17)180801
• Combination Product (y/n): N
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

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: Nurse
• Device Expiration Date: 08/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• 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