MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS XTS PHOTPHERESIS SYSTEM

Lot Number D701-KIT

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Loss of Power (1475)

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

Event Date 03/18/2015

Event Type  malfunction  

Event Description

The customer reported that the instrument had a power failure during a treatment.The power failure was accompanied by a smell described as a burning electronic smell.The customer requested assistance w/releasing the kit from the instrument so that a manual return could be done.The customer stated that the bowl was easily removed from the centrifuge.The clinical svc specialist (css) advised the customer to lock the front wheels, remove the right side outer panel, press the blood pump door seal release button, then simultaneously push on the blood pump door while pulling on the blood pump door latch.Customer was then able to open the blood pump door latch.Customer was then able to open the blood pump door and release the fluid logic module.The customer stated that he did not need any assistance to compete the manual blood return.The css called the customer back in order to f/u.The customer stated the manual return of the treatment volume had been completed successfully.The customer reported that uvadex had been added to the treatment volume, then the power had failed after about three to five minutes of photoactivation, after which the manual return was completed.The pt was reported to be in stable condition.The customer reported that no other alarms had occurred during the treatment.The customer state that their internal biomedical engineer had checked the instrument and had found one component which appeared to be burned.The biomedical engineer called and reported that the power entry module and fuse holder had burned out.Svc order, (b)(4), was dispatched to replace the power entry module, fuses and power cord.The kit was not returned for eval.

Manufacturer Narrative

A batch record review for lot d701 was performed.There were no nonconformance's associated w/this lot.The lot met release requirements.Trends were reviewed for complaint categories, no power and smell-direct/indirect.No trends were detected for these complaint categories.No cpap's were initiated for complaint categories, no power and smell-direct/indirect.Svc order, (b)(4), feedback: the svc tech replaced the power entry module, the power cord and fuses.The tech was able to power up the sys and complete the sys checkout successfully.No further action required.Svc resolved the issue.The assessment is based on info available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met spec based solely on the info provided by the customer.Complaints are monitored through tracking and trending.It a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).

• Brand Name: THERAKOS XTS PHOTPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: 10 n. high st.; suite 300; west chester, PA 19380 ; 8554229115
• MDR Report Key: 4651099
• MDR Text Key: 16542589
• Report Number: 2523595-2015-00087
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2015

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: Health Professional
• Device Expiration Date: 01/01/2020
• Device Lot Number: D701-KIT
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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: 70 YR
• Patient Weight: 63