MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS KIT

Lot Number D364

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 02/24/2016

Event Type  Injury  

Event Description

Unable to prime cellex photopheresis kit lot # d364, expiry date 10/01/2017 due to multiple re-occurrences of alarm "prime 1".Two kits were used without success.The mfr was notified of the event and the kits were saved and sent for eval.Report pending.Reprocessor - address: u.S.

• Brand Name: CELLEX PHOTOPHERESIS KIT
• Type of Device: CELLEX PHOTOPHERESIS KIT
• Manufacturer (Section D): THERAKOS INC.; bridgewater
• MDR Report Key: 6547339
• MDR Text Key: 74594697
• Report Number: MW5069578
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

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: 10/01/2017
• Device Lot Number: D364
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CELLEX PHOTOPHERESIS DEVICE: SN #(B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90