MAUDE Adverse Event Report: HARMAC MEDICAL PRODUCTS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number B725-KIT

Device Problems Break (1069); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2014

Event Type  malfunction  

Event Description

Customer called to report centrifuge bowl break during cycle 1.Customer aborted the procedure and did not return any blood or products to patient.Customer stated there was a noise which sounded like the centrifuge bowl lost pressure.Customer stated they have cleaned the centrifuge bowl and noted the centrifuge bowl was cracked at the bottom.Css asked the patient was alright, customer stated, yes patient was fine and they have started a new treatment for the patient.Service order # (b)(4) will be dispatched as per customer's request.Css asked if kit was available to return for investigation, customer stated no the kit has been discarded.

Manufacturer Narrative

A batch review of lot b725 was performed and there was one nonconformance associated with this lot.At the time of investigation there was no trend for xts centrifuge bowl leak/break.(b)(4) created (b)(4) for further investigation.Service order feedback from the field engineer replaced failed pump and ran checkout, tested ok, unit ok.The assessment is based on information available at the time of the investigation.No product was returned; therefore, a root cause could not be determined based solely on the information provided by the customer.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 3853522
• MDR Text Key: 4413587
• Report Number: 2523595-2014-00099
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2014

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: Health Professional
• Device Expiration Date: 08/01/2018
• Device Lot Number: B725-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/03/2014
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 98