MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX PHOTOPHORESIS SYSTEM; CELLEX,

Lot Number D114-KIT

Device Problems Hole In Material (1293); Leak/Splash (1354); Loose or Intermittent Connection (1371); Noise, Audible (3273)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A review of kit lot d114 was performed.There were no nonconformances associated with this lot.This lot met release requirements.The uvadex lot number was not provided.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 alarm #7: blood leak? (centrifuge chamber) and drive tube leak/break.No trend was identified.However, a corrective and preventive action was initiated for complaint category drive tube leak/break.Feedback from (b)(4) is pending.A supplemental medwatch will be submitted upon receipt of information.This assessment is based on the information available at the time of the investigation.Investigation is still in progress as the photo analysis is not complete at the time of this report and the kit and smart card have not been received for investigation at the time of this report.A supplemental report will be filed when the investigation is complete.(b)(4).

Event Description

Customer reported a loud noise from the instrument when they were near the end of the treatment.The centrifuge chamber was full of blood and it appeared that the tubing from the centrifuge bowl had loosened/stretched and touched the centrifuge wall.There was a hole in the tubing and a blood leak.Patient reported as feeling well.(b)(4) was generated.The customer has provided photos for analysis.Customer will return the kit and smart card for investigation.

Manufacturer Narrative

The kit and photos associated with the complaint were returned for the analysis.Review of the returned kit components and photos confirmed the upper bearing stop had delaminated as the upper stop on the drive tube was pulled axially along the drive tube and it had moved.The root cause of the reported leak is likely that the upper bearing stop delaminated and allowed the upper drive tube to twist and break resulting in a leak.A corrective action has been initiated to address drive tube surface improvements.A second corrective action was initiated to investigate bearing stop delamination.Service order, (b)(4), was completed.The service engineer successfully replaced the centrifuge leak defector strip, the drive tube retainer clips and the pump head.A system checkout was completed and the instrument was returned to service.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHORESIS 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: 5090932
• MDR Text Key: 26565750
• Report Number: 2523595-2015-00232
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Report Date: 08/25/2015

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: 04/01/2017
• Device Lot Number: D114-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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: 67 YR
• Patient Weight: 64