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

Model Number CLXUSA

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Twisted/Bent (2981); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2021

Event Type  malfunction  

Event Description

The pheresis tubing from the kit was loaded properly into the pheresis machine and the patient was connected to the tubing and pheresis machine.The treatment had been started.The machine alarm sounded, and the nurse observed that the tubing above the centrifuge was twisted.It then broke apart and resulted in a blood leak from the broken tubing.The pheresis treatment was stopped and the patient was safely disconnected from the pheresis equipment.However, there is infection risk from the disruption in the patient/pheresis connection.There was minimal blood loss from the patient but there was blood lost from the donor blood unit which was used as primer.The donor blood unit was also exposed and had to be discarded.

• Brand Name: CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 1425 us route 206; bedminster NJ 07921
• MDR Report Key: 11214171
• MDR Text Key: 228170101
• Report Number: 11214171
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2021

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 Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• 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: 01/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Weight: 60