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

Catalog Number UNKNOWN- DIALYZER

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

Patient Problems Hemolysis (1886); Blood Loss (2597)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a clinical review was performed in relation to the events reported.Based on the information obtained, there was no device malfunction reported.The nurse manager confirmed that the cause of the multiple blood leak alarms was the patient¿s liver condition.The multiple blood leak alarms were related to hemolysis, secondary to warm autoimmune hemolytic anemia, and not a dialyzer reaction or device malfunction.This diagnosis was provided per a hematology consultant.The patient was already hospitalized at the time of the hemodialysis event on (b)(6) 2020.The patient hospitalization was (b)(6) 2020 through (b)(6) 2020 for chest pain with nausea, vomiting and diarrhea unrelated to any fresenius device, product, or hemodialysis therapy.The patient was not able to complete hemodialysis therapy on the date of the event, (b)(6) 2020; however, the patient has continued with their regular subsequently scheduled treatments.Based on the information available, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there is no allegation of a device malfunction or deficiency reported for the hospitalization.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

An acute user facility contacted fresenius technical support (ts) to report multiple blood leak alarms that occurred during a patient¿s hemodialysis (hd) treatment.The alarms occurred as soon as blood reached the dialyzer.The dialysate was tested with blood leak test strips, and each time the results were positive.After the first event, the staff reset-up the machine with new bloodlines and a new dialyzer.The same thing happened and the machine alarmed with another blood leak alert.The machine was pulled from service and the patient was moved to a different machine.The patient was re-setup with a dialyzer from a different manufacturer on the second machine, and the blood leak alarm reoccurred once their blood reached the dialyzer.After the staff reset the alarm the patient was able to continue their treatment, and seemingly without further interruption; however, during the call to ts, a blood leak alarm occurred once again, and the dialysate tested positive for blood.Additional information was obtained through follow up with a biomedical technician (biomed) familiar with the reported issue.The biomed stated there were no true blood leaks.According to the biomed, the patient had severe liver damage which was masking itself as blood leaks.The staff was reportedly unaware of the patient¿s liver condition at the time.Their condition, identified as liver disease, became known when results from the patient's blood tests came back.The liver disease was causing the patient¿s red blood cells to ¿leech¿ or ¿lyse¿ into the dialysate.The biomed confirmed the issue followed the patient from one machine to another, both of which were fresenius 2008t machines.The clinic started the patient with fresenius optiflux dialyzers (unknown catalog and lot numbers), and then adjusted the prescription by transitioning the patient to a baxter revaclear dialyzer.Each time, the machine alarmed appropriately with a blood leak alert and the dialysate tested positive for blood.The biomed reported they also tried using bloodlines, manufactured by fresenius (unknown catalog and lot numbers) from different lots as well.Per the biomed, the medical professional thought it was unlikely that the multiple dialyzers cartridges from different lots and manufacturers, and two different dialysis machines, were suffering the same failure of blood leaks.The patient had been undergoing dialysis on a different make and model of dialysis machine with no reported history of blood leak alarms.It was further mentioned that the patient was admitted to the hospital, however the biomed did not know what the patient was admitted to the hospital for.More details were revealed via follow up with the hospital services nurse manager (nm).The nm stated the hospitalization was for a primary diagnosis of chest pain with a secondary diagnosis of nausea, vomiting, and diarrhea.The diagnoses were unrelated to any fresenius device, product, or hd therapy.The nm confirmed the cause of the multiple blood leak alarms was attributed to the patient¿s liver condition.The multiple blood leak alarms were related to hemolysis, secondary to warm autoimmune hemolytic anemia, and not a dialyzer reaction or device malfunction.This diagnosis was provided by a hematology consultant.The patient was not able to complete hd therapy on the date of the event, however, the patient has continued with their regular subsequently scheduled treatments.The products were not reported to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, a search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Two lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on each of the lots which were 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 lots 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: DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• MDR Report Key: 10468811
• MDR Text Key: 204998824
• Report Number: 1713747-2020-00357
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- DIALYZER
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR