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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190610
Device Problem Pumping Problem (3016)
Patient Problem Loss of consciousness (2418)
Event Date 08/12/2021
Event Type  Injury  
Manufacturer Narrative
Plant investigation: the plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k2 hemodialysis system and the serious adverse event(s) of loss of consciousness (loc), which warranted evaluation/observation in the er following completion of treatment. The cause of the patient¿s loc was never clinically identified, however the outpatient dialysis clinic¿s bmt attributed the event(s) to a 2008k2 hemodialysis system bicarbonate pump failure (¿not pulling¿). Limited information precluded a more in-depth investigation into the clinical events. While advances in technology have significantly reduced the number of serious adverse events incurred during hd therapy, the 2008k2 hemodialysis system cannot be excluded from having a possible causal or contributory role in the serious adverse event(s). There is no tangible or objective evidence indicating the 2008k2 hemodialysis system malfunctioned on (b)(6) 2021, as the bicarbonate pump was discarded after replacement. However, given the lack of definitive causality, treatment data, patient demographics, discharge summary and machine records, the 2008k2 hemodialysis system cannot be disassociated from the event(s). Furthermore, without the patient¿s medical history, it is unknown if any extraneous factors could have affected the patient¿s hemodynamic stability during hd therapy.
 
Event Description
It was reported to fresenius that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) lost consciousness during hd therapy on (b)(6) 2021. Follow-up with the facility clinic manager (cm) confirmed the patient lost consciousness approximately 10 minutes into hd therapy on (b)(6) 2021. The patient was given a normal saline bolus (volume unknown) and while preparing to initiate cardiopulmonary resuscitation measures, the patient regained consciousness. The patient continued treatment utilizing the same 2008k2 hemodialysis system without further issue. Following treatment, the patient was sent to the emergency room (er) via medical transport and kept overnight for observation (<24 hours). Per the cm, no medical intervention was provided at the hospital. Additional information was requested (e. G. , machine records, treatment record, patient demographics, discharge summary), however the request was declined. The 2008k2 hemodialysis system was not sequestered following the event(s), and no rationale was provided. However, the cm stated no additional issues occurred with the machine until (b)(6) 2021 when the bicarbonate pump failed during therapy. No treatment data, machine records and/or functional compliance testing was supplied for (b)(6) 2021. The bicarbonate pump was later replaced on (b)(6) 2021, and is unavailable for manufacturer evaluation, as it was discarded. Limited information prevents the completion of a detailed and thorough investigation.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key12479008
MDR Text Key271647259
Report Number2937457-2021-01907
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190610
Device Catalogue Number190610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2010
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: 09/16/2021 Patient Sequence Number: 1
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