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

Catalog Number 2040

Device Problems Break (1069); Mechanical Problem (1384); Torn Material (3024); Noise, Audible (3273)

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

Event Date 04/15/2014

Event Type  malfunction  

Event Description

Patient being treated in ecp on cellex machine.After 783ml wbp there was a loud crash from inside the centrifuge chamber(flat tire sound).Machine turned off immediately.Patient alert x3.Denied dizziness, pain, or shortness of breath.Drive tube and centrifuge still secured onto frame and magnetic clamps holding drive tube still in place.There was an inch tear into the drive tube shaft about 3 inches above lower magnetic clamp.Drive tube tore part of magnetic strip off wall of centrifuge chamber and caused some scrapes in the wall of chamber.Bp checked frequently (every 10-15 minutes).Patient laid flat in chair, and denied complaints of (c/o's) dizziness or shortness of breath (sob).Np paged and ordered to give 0.9ns and draw cbc and type and screen.Second np also came to assess the patient and stated to give 750ml of total 0.9ns.Md also paged.Repeat cbc after treatment aborted: hbg 8.1, hct 22.8 patient sitting up and 14:45pm and denies c/o's dizziness, no sob or pain.Patient transferred clinic at 15:00pm via wheelchair (w/c) for transfusion of 1 u packed red blood cells (prbc).Cellex kit sequestered by biomedical and will be sent to therakos for inspection.

• Brand Name: CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL, KIT
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• MDR Report Key: 3962820
• MDR Text Key: 4609027
• Report Number: 3962820
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/15/2014

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: Nurse
• Device Catalogue Number: 2040
• Device Lot Number: B350/330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2014
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 55