MAUDE Adverse Event Report: THERAKOS THERAKOS XTS PHOTOPHERESIS SYSTEM

Lot Number E725 - KIT

Device Problems Fluid/Blood Leak (1250); Device Emits Odor (1425); Smoking (1585); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e725 was reviewed.There were no non-conformances.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 noise, smell-direct/indirect, smoke - direct/indirect, centrifuge bowl leak/break and clot observed and no trend was detected for these categories.This assessment is based on the information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).Device not returned.

Event Description

Physician called and reported an event from the same day.The 1st cycle was normal, in 2nd cycle they could hear an unusual noise from the centrifuge.They could also feel a strong smell as of burned plastic and saw smoke.The bowl was very hot and they could see red cells clamped together "as clotting".There was also some blood sticking to the outside of the bowl so there had been a leak.They aborted the treatment without blood return and discarded the kit.Physician said the patient, a female child, was stable and he was not concerned about her condition due to the event.He would soon retrieve her lab counts but did not think a transfusion would be needed.He estimated approx.350 ml blood had been lost.No further patient information was provided.There was no visible damage to the centrifuge.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6080163
• MDR Text Key: 59572753
• Report Number: 2523595-2016-00245
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Physician
• Type of Report: Initial
• Report Date: 10/13/2016

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: No Information
• Device Expiration Date: 06/01/2021
• Device Lot Number: E725 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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