MAUDE Adverse Event Report: OGDEN MANUFACTURING OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

Catalog Number 0500316E

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Code Available (3191)

Event Date 08/20/2011

Event Type  Injury  

Event Description

Facility reported that since home training was started on (b)(6), a reduction in platelets were observed.Between 65-80 x 10^9 liter were observed in (b)(6) during review of the weekly blood tests for the week.This pt has never had a reaction during dialysis in the hosp or dialysis with gambro revaclear dialyzer.The symptoms observed for this pt are the reduction in platelets and co-agulation at the needle from the beginning of treatment which let to replacement of the needle up to 3 times during the treatment.In (b)(6), the pt was referred to hematology and tested for an allergy to heparin and both tests were negative.The pt primed with 800ml saline 0.9%, 500u heparin bolus and 500u/hr, medisstem buttonhole bh-7006, combiset 03-2622-3.

Manufacturer Narrative

The causes of thrombocytopenia with increased thrombosis are multiple.A complete chart review would be required to identify potential etiologies in this case.That increased thrombosis is also reported, implies the risk or thrombocytopenic hemorrhage is not increased.A relatively low dose of heparin is being used in this pt and wonder if activated clotting times or objective methods have been used to appropriately adjust the dose.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding complaints of deaths or serious injuries received between (b)(6) 2011 to (b)(6) 2013.

• Brand Name: OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
• Manufacturer (Section D): OGDEN MANUFACTURING; ogden UT
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th st.; ogden UT 84404
• Manufacturer Contact: tanya taft ; 920 winter st; waltham, MA 02451 ; 7816999000
• MDR Report Key: 4112636
• MDR Text Key: 4938341
• Report Number: 1713747-2014-00441
• Device Sequence Number: 1
• Product Code: FJI
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Catalogue Number: 0500316E
• Device Lot Number: 12HU03017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2012
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other