MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500318E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cardiac Arrest (1762)

Event Date 09/24/2018

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).A records review and an investigation of the device manufacturing records could not be conducted, as no machine serial number was provided.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A user facility clinical manager reported that a dialyzer blood leak occurred 15 minutes after the initiation of the patient¿s (b)(6) 2018 hemodialysis (hd) treatment using a fresenius optiflux 180nre dialyzer finished assy.The blood leak was noted as being an internal blood leak.The leak was not visually observed.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 100ml.Upon follow up with the clinical manager, it was learned that the patient coded during their (b)(6) 2018 treatment, and was taken to the hospital for cardiac issues.The complaint device was reportedly discarded and cannot be returned.Clinical investigation: on 09/26/2018 a clinical manager from a hemodialysis (hd) clinic reported that there was a dialyzer blood leak which occurred approximately 15 minutes after the initiation of a patient¿s treatment on (b)(6) 2018.The blood leak was noted to be internal which was not visually observed.The 2008t machine alarmed appropriately that there was a blood leak.Blood leak test strips were positive for the presence of blood.The patient had an estimated blood loss of approximately 100ml.Additional information was obtained during follow up on 09/27/2018.It was confirmed that the optiflux 180nre dialyzer had an internal blood leak during hd treatment.This male patient on 4 times weekly hd therapy for one month was 15 minutes into treatment when the machine alarmed with a blood leak which was confirmed with blood test strips as the leak was not visually observed.The treatment was stopped and the patient was reset up with new supplies on a new machine resulting in approximately 100ml blood loss.Fifteen minutes into treatment on the new machine, the patient coded.Treatment was stopped and the patient was transported to the hospital via emergency medical services.No resuscitative efforts were documented.The patient was still hospitalized as of 09/27/2018 and was confirmed that the patient has underlying cardiac issues including atrial fibrillation prior to the coding event.Hospital course is unknown.No further information was provided.The patient¿s medical history included end stage renal disease (esrd) on hd for one month, and atrial fibrillation.There is a temporal relationship between hemodialysis therapy on the 2008t machine and the patient event of coding with subsequent hospitalization.There is no documentation to show a causal relationship between the event and the 2008t machine, however, it is unknown if the blood loss resulting from the dialyzer blood leak could have caused or contributed to the event.The patient had pre-existing underlying cardiac issues including afib which is a common arrhythmia in dialysis patients and associated with a high risk of morbidity and mortality.Based on the available information a cause of the event cannot be confirmed.

Manufacturer Narrative

The plant investigation for this device is ongoing, please disregard the prior plant investigation, which was submitted in error.

Manufacturer Narrative

The reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• 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
• MDR Report Key: 7961010
• MDR Text Key: 123568788
• Report Number: 1713747-2018-00383
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2021
• Device Catalogue Number: 0500318E
• Device Lot Number: 18JU02012
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 75