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

Lot Number C128/437-KIT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Therapeutic Effects, Unexpected (2099); Test Result (2695)

Event Date 12/17/2014

Event Type  Injury  

Event Description

The treatment was completed with no issues and the pt was stable throughout the treatment.The pt's blood was drawn right before the treatment.The pt's lab results after the treatment showed pt-inr 1.33 and aptt > 180.The pt was still stable but the physician decided to admit the pt for medical intervention such as administering iv protamine sulfate.Labs were ordered for the pt for pt-inr and aptt levels on (b)(6) 2014.The lab results on (b)(6) 2014 were pt-inr 0.88 and aptt 28.7.The kit was not returned for eval.

Manufacturer Narrative

A batch record review of lot c128 was conducted.There were no non-conformances related to this type of event for this lot.The lot met release requirements.Trends were reviewed for this complaint category, other adverse event.In this case, the other adverse event was elevated pt/ptt levels.There were no trends detected for this complaint category.No capa was initiated for this complaint category.Based on the medical assessment, (b)(6) yr old female with chronic gvhd developed an increased aptt value of over 180.The pt's inr was 1.33.The pt was given heparin as their anticoagulant during treatment.Since the pt had increased bleeding time after treatment, the pt was given an antidote of heparin (protamine sulfate) and was hospitalized.Since medical intervention was necessary this case is serious and related to the treatment.The assessment is based on info 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 info 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.Kit unique device: (b)(4).Late report is being addressed as a nonconformance, (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; ste 140; bridgewater, NJ 08807
• MDR Report Key: 4454371
• MDR Text Key: 5423494
• Report Number: 2523595-2015-00013
• 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: 12/19/2014

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: 08/01/2016
• Device Lot Number: C128/437-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 49