MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS UVAR XTS

Model Number 6660

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/23/2013

Event Type  malfunction  

Event Description

Customer called to report he suspects drop in hematocrit is due to treatment procedure with uvar xts instrument.Name and function of complainant: therakos field trainer (fts) reported on behalf of customer.Therakos fts emailed to cts to report on behalf of customer, suspicion of a drop in the hematocrit levels of a pt had been observed over period of multiple treatment.Pt received transfusion on (b)(6) 2013.Started treatment on (b)(6) 2013, hgb 10.2; next 2 treatments on (b)(6) 2013, hgb 9.5; next 2 treatments on (b)(6) 2013, hgb 9.0; next 2 treatments on (b)(6) 2013, hgb 8.0.Fts spoke with customer and discussed the need to do a manual return of residual red blood cells following frequent xts ecp treatments in order to maintain hematocrit.Currently they are not doing this.Customer did not return the kit for investigation.Fts confirmed that customer has the most recent copy of the xts operator's manual (rev j) and that it contains the instructions for manual return of the residual red blood cells (rbcs) to maintain hematocrit.Customer stated will try this method with the next treatment procedure.They will call at that time if they need further assistance.

Manufacturer Narrative

Batch record review could not be conducted because lot number was not provided.A follow-up attempt was made to obtain a lot number, but cts rep was not able to obtain info.Complaint lot review could not be conducted since no lot number provided.The assessment is based on info available at the time of the investigation.The instrument performed as intended; however, therakos has elected to report this incident due to the pt transfusion.(b)(4).

• Brand Name: THERAKOS UVAR XTS
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, ste 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3747922
• MDR Text Key: 18296865
• Report Number: 2523595-2014-00010
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2013

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 Model Number: 6660
• Device Lot Number: UNKWN KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention