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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190713
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 02/22/2021
Event Type  Injury  
Manufacturer Narrative
Clinical investigation: there is a temporal relationship between hemodialysis (hd) therapy utilizing the fresenius 2008t machine with cdx and the patient event of cardiopulmonary arrest with subsequent hospitalization resulting in open heart surgery and seizure. However, there is no documentation of a causal relationship between the adverse event and use of the machine. Additionally, there is no allegation of a machine malfunction or deficiency reported for this adverse event. The cause of the patient¿s cardiopulmonary arrest during hd treatment was attributed to a physiological condition for which the patient required open heart surgery. Cardiovascular disease is present in greater than 50% of patients undergoing dialysis with 40% of these patients having coronary heart disease. Based on the available information and no allegation of a malfunction or deficiency, the fresenius 2008t machine with cdx can be excluded as the cause of the patient¿s cardiopulmonary arrest with subsequent hospitalization resulting in open heart surgery and seizure. Plant investigation: the plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported by a user facility biomedical technician (biomed) that a fresenius 2008t machine passed functional testing and was authorized for release back to service following an adverse event. Additional information was obtained through follow-up with the hemodialysis registered nurse (hdrn). The hemodialysis (hd) patient was approximately 2 hours and 50 minutes into treatment on the 2008t machine with approximately 1 hour and 30 minutes remaining in the treatment when they complained of cramping. This was a common occurrence for this patient. The patient¿s treatment was turned down to minimum and they were administered 200ml of normal saline (ns). The patient reported feeling fine other than the cramping. A short time later (time not provided) the nurse heard the patient making loud gasps with abnormal breathing. The patient then became unresponsive. The patient¿s treatment was discontinued and 500ml of ns was administered. Cardiopulmonary resuscitation (cpr) was initiated and the automated external defibrillator (aed) was retrieved. 911 was called. Shock was advised with the aed. A post-review of the aed indicated the patient was in ventricular tachycardia (v-tach) at the time of the event. The patient was transported to a local hospital and then transferred to a different hospital to meet the patient¿s needs. The patient was intubated for two days and then extubated to undergo open heart surgery. Subsequently, the patient suffered a seizure post-surgery. The patient remains hospitalized at this time. The hdrn stated there were no issues with the fresenius 2008t machine during the patient¿s treatment. The patient¿s adverse event was due to a physiological condition and not related to any malfunction or deficiency of the machine. The machine passed all functional testing and was released to be put back into service. The only recent change with the patient was her dry weight (not provided). The nephrologist had increased her dry weight. No reason for the change or weight was provided. No additional information was obtained.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
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 Key11465454
MDR Text Key239397526
Report Number2937457-2021-00408
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190713
Device Catalogue Number190713
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 Received09/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2016
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: 03/11/2021 Patient Sequence Number: 1
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