MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

Patient Problem Anemia (1706)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e215 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint categories, tubing leak, equipment performance, and low hemoglobin.No trends were detected for these complaint categories.From a device perspective, there was a device malfunction.This case is reportable as a mdr due to the device malfunction and the medical intervention of the transfusion that was administered to the patient.The medical intervention of the transfusion was required due to the patient's adverse event of low hemoglobin.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.Adverse event terms: anemia.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a tubing leak.The customer stated that the instrument was returning blood from the return bag and that photoactivation had not started yet, when the pump tubing organizer (pto) popped out of its position after 1599ml of whole blood processed.The customer reported that the return pump tubing also popped out of its position as well.The customer stated that there was a pump alarm, but they could not remember the alarm number.The customer reported that they replaced both the pto and the return pump tubing, but then they noticed a leak around the return pump.The customer stated that the treatment was aborted with no return of blood/product to the patient.The customer reported that the patient was in stable condition.The customer stated that there was151ml and 206ml of volume remaining in both the treatment and return bags, respectively.On (b)(6) 2011, the patient's treating physician reported that due to a hemoglobin drop from 83g/l prior to treatment to 75g/l after treatment, the patient needed a transfusion of two units of packed red blood cells.The reportable malfunction was reported under 2523595-2016-00281.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6197481
• MDR Text Key: 63054143
• Report Number: 2523595-2016-00282
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 12/21/2016

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: Nurse
• Device Expiration Date: 09/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: E215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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: 59 YR
• Patient Weight: 68