MAUDE Adverse Event Report: THERAKOS INC THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number C149 - KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoxia (1918)

Event Date 02/19/2015

Event Type  Injury  

Event Description

O2 given to patient after treatment; system primed normally.Received red blood cell pump alarms and interface too high - bowl full of red blood cells (rbcs).Paused flow, bos threshold increased to attempt to remove rbcs from bowl, no effect although rbc pump turning at approx same speed as collect, so bowl was stopped.Changed to double needle mode (dnm) and connected patient - received multiple collect pressure alarms due to poor cvc function and one bowl stop (10 minutes pause).Return pressure alarms also present when child was active.Smart card failure alarms later in treatment- card removed and reinserted and the treatment continued.After a pause (but not bowl stop) the cellex went to purging air and return rate could not be decreased.Reporter switched back to single needle mode (snm) and blood bag to continue process.Temperature warning - fan placed in front of centrifuge, no hemolysis seen.At this time decided to go to buffy code collection (bc) early.Bc collected and treatment completed.Patient condition stable throughout - intentionally made 30 mls -ve balance during treatment to reduce +ve balance at end.Po2 level 91% pre-treatment, fell to 84% during pa (no fluids to/from patient at that time), o2 given, po2 at end of treatment 92%.Bp and p high pre-treatment but paediatric haematologist considered it normal at end of treatment.Small blood clot seen in bowl at take down of kit.Customer will return smart card for evaluation.

Manufacturer Narrative

A review of lot c149 was performed and there were no non-conformances for this lot.This lot met all release requirements.Trends were reviewed for all complaint categories and no trend was detected for complaint categories: access issues, alarm #16: collect pressure, alarm #17: return pressure, alarm #6: smart card failure, alarm #33: pause timeout, temperature concern, clot observed and for other adverse event; capa (b)(4) was initiated for alarm #16: collect pressure.This capa is not closed; an upward trend was detected for alarm #45: red blood cell pump alarm.Capa (b)(4) and capa (b)(4) were initiated for complaint category alarm #45: red blood cell pump alarm.These capas are now closed.The assessment is based on information available at the time of the investigation.The instrument performed per specification, but since medical intervention was necessary (o2 given to patient), this event has been assessed as reportable.The product return investigation is still in progress at the time of this report.A supplemental report will be filed when this investigation is complete.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 10 north high street suite 300; west chester, PA 19380
• MDR Report Key: 4584649
• MDR Text Key: 5453531
• Report Number: 2523595-2015-00053
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Lot Number: C149 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO
• Patient Weight: 10