MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number D366 - KIT

Device Problems Fluid/Blood Leak (1250); Vibration (1674); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot d366 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 drive tube leak/break and alarm #7: blood leak? (centrifuge chamber) and no trend was detected for either of these categories.This assessment is based on 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

Customer called to report drive tube leak and alarm #7 (blood leak, centrifuge chamber) at approximately 733ml whole blood processed.Customer said the leak originated near the top bearing on drive tube proximal to the centrifuge bowl.Customer confirmed both drive tube bearing were still in their bearing retainer clips after the leak had occurred.Customer said that blood had sprayed inside the centrifuge chamber, but no obvious signs of damage were observed to bearing retainer clips, fluid leak detector, centrifuge wall, or any other component in the centrifuge chamber.Customer said just prior to leak, instrument had begun to "vibrate" significantly, so they stopped the centrifuge bowl, visually confirmed no leak was observed, and visually confirmed drive tube and bowl were loaded correctly.Customer said they then resumed the procedure, but shortly after the centrifuge bowl spun up to full speed, the leak and alarm occurred.Customer reported that the patient was stable, and would not require any fluids or blood replacement.Customer said they would take the instrument out of service, and would like a call back from technical service (ts) to determine if service is necessary.Customer did not return product for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS; hampton NJ 08827
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5812007
• MDR Text Key: 50961032
• Report Number: 2523595-2016-00157
• Device Sequence Number: 1
• Product Code: LNR
• 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
• Report Date: 06/28/2016

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: 11/01/2017
• Device Lot Number: D366 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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