MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F160NRE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500316E

Device Problem Fluid/Blood Leak (1250)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Loss of consciousness (2418)

Event Date 09/11/2017

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A hemodialysis (hd) patient was undergoing a regularly scheduled hd treatment when the fresenius 2008k2 hd machine alarmed for a blood leak approximately 40 minutes after the treatment started.Blood test strips were used and positively confirmed the presence of blood.The patient¿s treatment was interrupted and the user facility staff replaced the dialyzer with a new one; however, the bloodlines were not replaced at this time.The patient¿s treatment was restarted, however, approximately 45 later, the machine alarmed again for a blood leak.Blood test strips were again used and positively confirmed the presence of blood.In addition, blood was visibly seen in the dialysate.The patient¿s blood pressure (b/p) was 105/69.About 50 minutes later, the patient was found unresponsive.The patient was disconnected from the hd machine and cardiopulmonary resuscitation (cpr) was initiated and automated external defibrillator (aed) was applied to the patient.It was reported by the user facility nurse that the patient did not experience any blood loss.Emergency medical services (ems) transported the patient to the hospital but the patient subsequently passed away.It was stated that the patient went into cardiac arrest prior to passing away but this could not be verified.This submission documents the first reported dialyzer blood leak that had occurred during treatment.The complaint device was discarded by the user facility therefore it is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

During follow up, it was clarified that the lot number for the dialyzer used during the first reported blood leak was unknown.Plant investigation: the device was not returned to the manufacturer for physical evaluation and the lot number was not provided.Distribution records were reviewed to identify potential lots of this product shipped to the customer for the three (3) month time frame which immediately preceded the event.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process related to this report.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.A clinical investigation was performed to identify a causal relationship between the patient's hemodialysis treatment and the patient passing away.As a death certificate could not be obtained, limited information was available for review.With limited information, the causality of the reported incident could not be determined.There remains a temporal association between the reported adverse events and the use of the dialyzer for hemodialysis treatment.

• Brand Name: OPTIFLUX F160NRE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6946530
• MDR Text Key: 89220971
• Report Number: 1713747-2017-00327
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0500316E
• Device Lot Number: 17CU06028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 10/20/2017
• 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): Death; Required Intervention
• Patient Age: 94 YR