MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PROCEDURAL KIT; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Model Number CLXUSA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

One tube attached to a collection pump became detached from the kit.Kit was able to be primed and procedure started without any alarms or problems.Blood collection was completed and establishing separation for buffy coat when leak was noted.Kit was collected for investigation, and there was a blood loss of ~200ml.Patient was stable, able to start a new procedure without complications or adverse reactions.

• Brand Name: CELLEX PROCEDURAL KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 1001 us highway 202; raritan NJ 08869
• MDR Report Key: 15797186
• MDR Text Key: 303638449
• Report Number: 15797186
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2022

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 Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Device Lot Number: L322/842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Sex: Female