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U.S. Department of Health and Human Services

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

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THERAKOS, INC. CELLEX; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL Back to Search Results
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.
 
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Brand Name
CELLEX
Type of Device
SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
Manufacturer (Section D)
THERAKOS, INC.
1425 us route 206
bedminster NJ 07921
MDR Report Key11214171
MDR Text Key228170101
Report Number11214171
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Number of Events Reported1
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 NumberCLXUSA
Device Catalogue NumberCLXUSA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/14/2021
Event Location Hospital
Date Report to Manufacturer01/22/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age6205 DA
Patient Weight60
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