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

Lot Number C146 - KIT

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

Patient Problems Abdominal Pain (1685); Pain (1994)

Event Date 01/20/2015

Event Type  Injury  

Event Description

During a css training on site, nurse reported that patient, (b)(6) year old girl with acute gvhd in skin and gut, complains about increased abdominal pain on days of ecp treatments.The patient had bone marrow transplant in late (b)(6) and started ecp on (b)(6).Patient is currently treated twice biweekly with blood prime procedures.Patient previously had a reaction to heparin (reported in 2523595-2014-00299/(b)(4)) and is since then treated using acd-a.Nurse stated they doubt the patient really has increased pain after ecp and if so, if it is related to ecp.Nurses stated the treating physician could not see any medical reason for the increased pain.Css has requested additional information regarding other medication and the patient's medical history: temperature 36.5c before, 37.4c after treatment, acd-a was used at a ratio of 10:1, calcium was distributed at 25 ml/h as precaution.The provided treatment information concerns the last patient treatment, on (b)(6) 2015.Weight (b)(6) kg, hct unknown, hgb 5.3 mmol/l, platelets 59 10^9/l; blood pressure 127/82 before, 130/101 after treatment.Temperature 36.5c before, 37.4c after treatment.Acd-a was used at a ratio of 10:1, calcium was distributed at 25 ml/h as precaution.Collect and return rates 10-15 ml/min.1002 ml whole blood processed, of which 276 ml (prime) + 42 ml (buffy coat) from prbc.Treatment volume 129 ml, photoactivation time 4.45 min; kit lot c146.Ecp history: treatment 14.10.14 using heparin and bloodprime.Treatment: patient is bleeding from the gut, protamine is used to neutralize the ani-clotting effects of heparin (from the 2.Series of ecp).From the 5.Treatment: we start using acd-a + infusion of calcium.The patient experiences an increased stomach pain on the days of ecp.Better now than with the heparin, but still worse than other days.Exams of the guts show improvement of the mucous membrane in general, but there is an ulcer of the pyloric channel.There is no sign of bleeding.The patient is on her 12th series of treatment, and is now treated every other week.

Manufacturer Narrative

A review of lot c146 was performed and there were no nonconformances associated with this type of failure for this lot.This lot met release requirements.Trends were reviewed for complaint category abdominal pain, and no trend was detected.No capa has been initiated for this complaint category.The assessment is based on information available at the time of the investigation.This case is related to report 2523595-2014-00299/(b)(4), as it is the same patient, same treatment series.Since patient had to receive calcium, therakos is reporting this event for the medical intervention.Kit unique identifier (udi) #: (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: 10 north high street suite 300; west chester, PA 19380
• MDR Report Key: 4522883
• MDR Text Key: 5410001
• Report Number: 2523595-2015-00040
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Lot Number: C146 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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: 11 YR
• Patient Weight: 33