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

Lot Number D128 - KIT

Device Problems Occlusion Within Device (1423); Increase in Pressure (1491); Insufficient Flow or Under Infusion (2182)

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

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d128 was performed.There were no nonconformances associated with this lot.This lot met release requirements.The uvadex lot number was not provided, as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, clot observed and alarm #17: return pressure.No trends were detected.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).Device not returned.

Event Description

Customer reported alarm #17: return pressure, at 583ml whole blood processed.Blood prime treatment in double needle mode.Customer stated that they had poor flow rate from start of the treatment.Collect and return flow rate was at 10ml/min.Customer stated that she could not reset the alarm because the return pressure was too high.Css advised customer to disconnect the return line from patient access, open the blue clamp and check the return pressure.Css advised to administer a saline bolus to waste to flush and check the return line.Customer stated that clots came out of the return line.Css advised customer to abort the treatment.Customer agreed and aborted the treatment.Customer reported the patient was in stable condition.The product was not returned for investigation.

Manufacturer Narrative

The instrument serial number was inadvertently omitted from the initial report.(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 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5264654
• MDR Text Key: 32918143
• Report Number: 2523595-2015-00301
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/01/2017
• Device Lot Number: D128 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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: 2 YR
• Patient Weight: 15