MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS CELLEX PROCEDURAL KIT; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Model Number CLXUSA

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Multiple return pressure alarms, was not able to resolved even iv access was working great.Can't flush line with saline as it is giving return pressure alarms even pt was not connected.Ecp kit chamber broke causing blood leakage and break in sterility.Procedure aborted without rinseback.Patient loss about 400ml of blood.".

• Brand Name: CELLEX PROCEDURAL KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS; 6603 femrite drive; madison WI 53718
• MDR Report Key: 15923611
• MDR Text Key: 304883216
• Report Number: 15923611
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• 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: L323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White