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

Lot Number D146 - KIT

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

This system was used for treatment.Kit lot d146 was reviewed.There were no non-conformances.This lot met all 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 category centrifuge bowl leak/break or alarm #7: blood leak? (centrifuge chamber).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.However, the most likely cause for this event is that the customer did not properly spike the anticoagulant and saline bags.The anticoagulant tubing was connected to the saline bag and the saline tubing was connected to the anticoagulant bag.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).

Event Description

Customer reported bowl leak.Instrument had made a strange noise then the blood leak alarm occurred and bowl stopped.Drive tube was twisted but still in bearings.Customer was sure that the kit had been installed properly.One-thousand (1000) ml blood had been processed.Patient was ok.Customer has not yet decided whether fluid replacement will be necessary.Css called customer for a follow-up on the patient's status.Customer stated that the patient had been stable and did not need a transfusion after the procedure.Patient went home and had not had further issues afterwards.Customer will not return product for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5510731
• MDR Text Key: 41045401
• Report Number: 2523595-2016-00059
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/25/2016

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: Nurse
• Device Expiration Date: 10/01/2017
• Device Lot Number: D146 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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 Weight: 60