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

Lot Number D130-KIT

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Device Displays Incorrect Message (2591); Malposition of Device (2616); Noise, Audible (3273)

Patient Problem Blood Loss (2597)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d130 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex 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 were detected for these complaint categories.However, corrective and preventive actions have already been initiated for drive tube leak/break.This assessment is based on information available at the time of the investigation.The analysis of the photos is still in progress at this time.A supplemental report will be filed when the analysis is complete.(b)(4).Device not returned to manufacturer.

Event Description

The customer's representative sent an email stating that after about 800 ml of whole blood processed, the customer heard a "crackle voice" from the centrifuge chamber.The customer immediately pressed stop in order to verify what had happened.When the customer opened the centrifuge chamber cover, he noticed a hole in the middle of the drive tube and a blood leak.The customer stated that the machine did give an alarm #7: blood leak (centrifuge chamber) alarm.The treatment was aborted and no blood was returned to the patient.This was a blood prime treatment using prbc.The customer stated that the total blood count of the patient had been controlled and the patient's values were normal after the treatment was aborted.The customer stated that the patient was "ok" after the procedure.The customer's in house biomed believes that this kit might be faulty, since in the photos he observed that the ring joint on the drive tube, which is normally right next to the bearing, had moved, which may have caused the problem.The customer considered this event as non- serious, as nothing had happened to the patient.Photos were submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photographs confirmed the leak and determined that the likely cause of the leak was delamination of the upper bearing stop from the drive tube.The delamination allowed the upper drive tube enough extended length to impact the centrifuge wall, causing a leak.The root cause for the delaminated bearing stop could not be determined.However, 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; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5279123
• MDR Text Key: 33731785
• Report Number: 2523595-2015-00312
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

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: 07/01/2017
• Device Lot Number: D130-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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 Age: 5 YR
• Patient Weight: 18