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

Lot Number C742-KIT

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)

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

Event Date 01/06/2015

Event Type  malfunction  

Event Description

The customer reported that pt occlusion alarms had occurred during cycle 1, just before the buffy collect phase.The customer paused the treatment and added "activase" to the pt's access device.When the customer resumed the treatment, a blood leak alarm occurred.The customer stated that no blood leak was visible in the centrifuge, but condensation was visible under the centrifuge lid.The customer stated that the centrifuge bowl had been spinning while the treatment was paused.The clinical services specialist (css) advised the customer that therakos recommends the treatment be aborted without returning the blood from the kit to the pt if a leak is suspected.The css advised the customer to consult the attending physician.The customer indicated that the treatment would be aborted as recommended, without returning any blood to the pt.The pt was reported to be in stable condition.No service order was generated.The kit was not returned for eval.

Manufacturer Narrative

A batch record review of lot c742 was conducted.There were no nonconformities related to the complaint.The lot met release requirements.Trends were reviewed for complaint categories occlusion pt alarm and centrifuge bowl leak/break.No trend was detected for these complaint categories.No capa was initiated for complaint categories, occlusion pt alarm and centrifuge bowl leak/break.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 specification based solely on the info provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us rte 22 east ste 140; bridgewater, NJ 08807
• MDR Report Key: 4460599
• MDR Text Key: 5323847
• Report Number: 2523595-2015-00016
• 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: 01/06/2015

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: 07/01/2019
• Device Lot Number: C742-KIT
• Other Device ID Number: 10705030100016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 22 YR