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

Lot Number C132 / 813 -KIT

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

Patient Problems Tingling (2171); Reaction (2414)

Event Date 01/21/2015

Event Type  Injury  

Event Description

The patient complained of tingling in her lips.Calcium gluconate 8.5% at 12ml per hour was administered iv into the return line of the cellex procedural kit by the physician due to use of the anticoagulant, acda, in the treatment.During the treatment, the patient complained about tingling in her lips.The physician increased the administration of the calcium gluconate to 14ml per hour.No further adjustments of the calcium, gluconate were made.The patient was stable at the time of the event.No service order was generated.The product was not returned for evaluation.

Manufacturer Narrative

A batch record review of lot c132 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint category, other adverse event.In this case the other adverse event was tingling of the lips.There were no trends detected for this complaint category.No capa was initiated for this complaint category.Based on the medical assessment, the (b)(6) female with chronic gvhd developed tingling in her lips.The patient was on acda anticoagulant.The patient was administered calcium gluconate 8.5% at 12 ml per hour.This case is serious and related to ecp.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.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).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, suite 140; bridgewater, NJ 08807
• MDR Report Key: 4493679
• MDR Text Key: 15962738
• Report Number: 2523595-2015-00024
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/21/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Lot Number: C132 / 813 -KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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: 42 YR
• Patient Weight: 49