MAUDE Adverse Event Report: THERAKOS, INC./ MALLINCKRODT THERAKOS CELLEX PHOTOPHERESIS SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Lot Number J364 CELLEX KIT

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2021

Event Type  malfunction  

Event Description

The therakos cellex photopheresis system procedural kit was loaded into the cellex photopheresis system.The kit was primed and passed the internal prime check.When the device's centrifuge began to spin faster to initiate treatment, the bowl of the kit detached from the centrifuge and broke into multiple pieces.The patients¿ blood that was within the kit was lost (estimated to be approximately 200 cc).A post cbc showed a normal hemoglobin of 11.7 and no intervention was needed.A follow up call the following day was made and the patient stated "i'm fine".Fda safety report id # (b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC./ MALLINCKRODT
• MDR Report Key: 11307022
• MDR Text Key: 231587328
• Report Number: MW5099301
• 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
• Report Date: 02/05/2021

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: 08/01/2022
• Device Lot Number: J364 CELLEX KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 76