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

Lot Number C122 - KIT

Device Problems Crack (1135); Particulates (1451); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Manufacturer Narrative

Batch record review of lot c122 was conducted.There was one nonconformance related to this complaint.This nonconformance was investigated and determined to be instrument - related and therefore unrelated to this complaint.As a corrective action, the instrument associated with this nonconformance was taken out of service for release testing.This lot met release requirements.Trends were reviewed for complaint categories, alarm #18: system pressure and centrifuge bowl leak/break and no trends were detected for these complaint categories.Capa (b)(4) was initiated for complaint category, alarm #18: system pressure and was closed as effective.Capa (b)(4) was initiated for complaint category, centrifuge bowl leak/break.A review of lot c122 shows no trends.This assessment is based on information available at the time of the investigation.A photo was sent by the customer and the kit was returned for analysis.Evaluation of the photo and returned kit is still in progress at the time of this report.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

Customer called to report two system pressure alarms after 300ml processed.Dual needle procedure.No blood prime.A 15/ml/min collect rate.Dual lumen power "port".Customer denied seeing any air or occlusions in the kit.Clinical service specialist (css) asked the customer to resume treatment and note the system pressure as the centrifuge ramps up to full speed during purge air.System pressure alarm occurred.Customer stated the system pressure was - 17mmhg.Css asked the customer to increase the collect rate to 20-25ml/min.Customer continued treatment and increased the collect rate to 20ml/min.System pressure alarm occurred again.Css asked the customer to open the centrifuge door and inspect for any clots or kinks.Customer did not see any.Css advised the customer to end the treatment and asked how much blood return she would give the patient.Customer stated there was 119ml in the return bag, but she was not going to give any blood back to the patient.Customer stated she received a blood pump error alarm during prime with this kit but she was able to reset the alarm.Patient was reported to be in stable condition.Customer called back to explain they did see a layer of something at the bottom of the bowl and they may have seen a crack in the bowl, but were not able to find it again.Customer stated that the bottom of the centrifuge bowl had a stringy looking particulate settled to the bottom of the bowl, that did not appear to be a clot.The customer also sent a picture of the bowl.Customer removed the bowl from the rest of the kit, and sent the kit to therakos for further investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffallo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4208886
• MDR Text Key: 51242254
• Report Number: 2523595-2014-00267
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/07/2014

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: 06/01/2016
• Device Lot Number: C122 - KIT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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 Age: 11 YR
• Patient Weight: 38