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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- 2008T MACHINE
Device Problem Fluid Leak (1250)
Patient Problem Cardiac Arrest (1762)
Event Date 09/24/2018
Event Type  Injury  
Manufacturer Narrative
Clinical investigation: see describe event or problem field. 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. 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 (b)(6) 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 (b)(6) 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 (b)(6) 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.
 
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Brand Name2008T MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7961106
MDR Text Key123799169
Report Number2937457-2018-03043
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN- 2008T MACHINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received09/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/12/2018 Patient Sequence Number: 1
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