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

Lot Number C124-KIT

Device Problems Expulsion (2933); Pressure Problem (3012)

Patient Problem Blood Loss (2597)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

Customer called to report that the system pressure dome "blew off the instrument" at 213 ml wb processed.Customer was in single needle mode and the event happened during the return phase.Customer reported that the instrument primed without alarms and no alarms were experienced during the procedure up to this point.The procedure was aborted and pt had a blood loss, but was stable and put on another instrument for a procedure.The kit was returned for eval.No svc order was generated.

Manufacturer Narrative

A review of lot c124 was performed and there were four non-conformances associated with this lot.None were related to the nature of this complaint.This lot met release requirements.A review of lot c124 shows no trends.A review of complaint categories shows no trend for "pressure dome membrane leak." capa (b)(4) and capa (b)(4) have already been initiated for further investigation of pressure dome membrane leaks.The returned kit was received for analysis.Examination of the system pressure dome showed evidence that it was not properly installed.When the pressure dome was cleaned and its diaphragm was fully seated, the pressure dome fit onto and stayed in place on a pressure sensor and a pressure test did not find any leaks.The reassembled system pressure dome performed as designed.Complaints are monitored through tracking and trending.If a trend is detected, further action will be taken.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MED PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 e; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4202566
• MDR Text Key: 18933502
• Report Number: 2523595-2014-00240
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• 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: 08/26/2014

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: 07/01/2016
• Device Lot Number: C124-KIT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 76