MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Air Leak (1008); Fluid/Blood Leak (1250); Material Frayed (1262); Loose or Intermittent Connection (1371); Cut In Material (2454); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e353 was reviewed.There were no non-conformances.This lot met all release requirements.A review of kit lot e353 shows no trends.Trends were reviewed for complaint categories drive tube leak/break, alarm #1: air detected, alarm #17: return pressure and no trend was detected for these categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the returned product evaluation has yet to be completed.A supplemental report will be sent once investigation is complete.(b)(4).Device not received for evaluation.

Event Description

Customer site physician reported the "tubing partially sheared off spattering blood around the inside." he stated the patient was stable as this was a blood prime procedure so the patient did not lose any blood, but the procedure was stopped immediately.They have an in-house biomed to clean and repair the device though it is down until the instrument is repaired.Customer stated there were no alarms during the saline prime, and no alarms during the initial blood prime using prbcs.Approximately 2 minutes after the patient was connected to the instrument, a return pressure alarm occurred.Operator paused treatment and checked the patient's line which was patent.She resumed, and shortly thereafter received an air detected alarm.She observed air in the return line, disconnected the patient, and observed air in the filter on the pto.She stated she resumed the procedure to attempt to purge the air from the return line, and upon resuming noticed the drive tube was "loose" and making noise in the centrifuge chamber.Customer stated he noted there was a slit in the drive tube.Customer stated there could have been an alarm #7: blood leak? (centrifuge chamber), but he is not sure as there was so much going on at that moment.They aborted the procedure at that point.Customer stated patient was fine.Customer will return kit/smart card for investigation.

Manufacturer Narrative

The kit and smartcard were returned for evaluation.Review of the smartcard data confirmed the occurence of the return pressure alarm and air detected alarm during the procedure.Examination of the kit confirmed the drive tube break.The cause of the break is a cut in the drive tube due to the drive tube rubbing against the top of the drive clamp.The root cause of the drive tube rubbing against the drive tube clamp could not be determined based on the information provided.Investigation completed.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; p.o. box 9001; hampton, NJ 08827
• MDR Report Key: 6245170
• MDR Text Key: 65077438
• Report Number: 2523595-2017-00014
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E353(17)180901
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

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: 09/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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