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

Model Number CLXUSA

Device Problems Communication or Transmission Problem (2896); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

Event Description

While injecting dose of medication, a peculiar "air" sound heard.No return of product noted on draw back from 1 of 3 from treatment bag.Clear fluid noted on floor.On further inspection of treatment bag, no communication between injection port and bag was noted; port led to tube outside the bag.The covering physician and therakos (vendor) were contacted.Spoke to therakos clinical consultant.The defect in the kit was reported and our proposed resolution (to spike bag utilizing non-vented dispensing pin w/ clave attached to introduce medication into product treatment bag) was explained.Per therakos clinical consultant, ok to proceed.Transfusion physician in agreement with therakos recommendations.The medication was introduced as proposed, and treatment was continued.

• Brand Name: CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 1425 route 206; bedminster NJ 07921
• MDR Report Key: 9145446
• MDR Text Key: 160886933
• Report Number: 9145446
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Device Lot Number: H324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23725 DA
• Patient Weight: 68