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

Lot Number KIT-D357

Device Problem Leak/Splash (1354)

Patient Problem Hyperglycemia (1905)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A review of kit lot d357 was performed.There were no trends or non-conformances related to this complaint.This lot met all release requirements.The (b)(4) lot number was not provided, since (b)(4) was not administered.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, drive tube leak/break and alarm #7: blood leak? (centrifuge chamber).No trends was identified for either of these categories.However, a corrective and preventive action has already been initiated for complaint category, drive tube leak/break.Feedback from service order, (b)(4), and the analysis of the returned smart card and photographs is still pending at the time of this report.A supplemental report will be filed when the investigation is complete.(b)(4).

Event Description

The customer called to report a drive tube leak and blood leak (centrifuge chamber) alarm at 419 ml of whole blood processed.No prior alarms were reported.The centrifuge bowl was intact and still in the bowl holder.The drive tube bearings were still inside the drive tube bearing retainer clips and there was no apparent or visible damage to the fluid leak detector strip, drive tube bearing retainer clips, centrifuge frame, centrifuge bowl holder, or sensitized drive tube assembly.Service has been dispatched.Customer is returning the smart card and photographs for evaluation.

Manufacturer Narrative

Service order report, (b)(4), feedback: the service technician successfully completed the system checkout procedure.The smartcard and photos were returned for analysis.A review of the smart card data indicated that prime was successfully completed and blood collection had started.After 419ml of whole blood processed, an alarm #7: blood leak (centrifuge chamber) and an alarm #18: system pressure alarms occurred.The treatment was then aborted.An evaluation of the photos indicated that the upper bearing stop had delaminated from the drive tube; damaging the drive tube and causing a leak.The root cause of the leak was upper bearing stop delamination which allowed the upper drive tube to twist and break.Corrective actions have already been initiated to address the potential root causes of drive tube delamination.(b)(4).Device not returned to manufacturer.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; hampton NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5482793
• MDR Text Key: 40115401
• Report Number: 2523595-2016-00052
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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: 02/10/2016

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: 09/01/2017
• Device Lot Number: KIT-D357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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 Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 85