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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190766
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Cramp(s) (2193); Dizziness (2194)
Event Date 03/11/2020
Event Type  Injury  
Manufacturer Narrative
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 2008t hemodialysis system and the adverse event(s) of cramping, a higher than expected uf total, lightheadedness, fall and subsequent hip fracture. Follow-up with the outpatient clinic¿s bmt and the patient¿s rn revealed no 2008t hemodialysis system alarms were noted during treatment. Per the bmt, the event was attributed to probable operator error. The etiology of the cramping is unknown; therefore, causality cannot be firmly established. However, muscle cramping is a common complication of hd therapy, occurring in anywhere from 33 to 86 percent of hd patients. The etiology of the patient¿s lightheadedness, fall, and subsequent hip fracture cannot be definitively established; therefore, causality cannot be determined. Hemodialysis causes significant fluid shifts, and elderly dialysis patients are susceptible to hypotensive events during and following dialysis. Additionally, postural hypotension, symptoms of hypotension and falls are common in elderly hemodialysis patients. Based on the information available, the 2008t hemodialysis system can be disassociated from causing the event(s). There is no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency caused the event(s). Additionally, the 2008t hemodialysis system passed all uf testing, and was returned to service without requiring intervention. However, the 2008t hemodialysis system cannot be excluded from having a possible contributory role in the events. Given the uf removal was 500 ml¿s greater then expected and the lack of treatment record(s), there is insufficient evidence to exclude the 2008t hemodialysis system from the events.
 
Event Description
A user facility biomedical technician reported that a hemodialysis (hd) patient experienced cramping toward the end of their hd treatment. Reportedly the settings on the 2008t hemodialysis system were correctly entered, however ¿based on the patient¿s dry weight,¿ the ultrafiltration (uf) was higher than expected (4. 0 liters instead of the expected 3. 5 liters). The treatment record was not provided; however, there were no reported issues during treatment, prior to the patient complaining of cramping toward the end of treatment. The registered nurse (rn) stated no adjustments were made to the patient's uf goal, uf rate, or total treatment time. The cramping reportedly subsided after the patient¿s blood was returned, and no medical intervention was required. The patient completed treatment and is reportedly continuing hd treatment without any further problems. The rn stated there were no machine alarms during the treatment, and the patient utilized the same scale pre/post treatment. The 2008t hemodialysis system was sequestered following the event. The bmt confirmed no alarms occurred during treatment prior to the event. The bmt performed a uf id problem checklist, and the 2008t hemodialysis system was found to be operating within manufacturer specifications and passed all uf testing. The bmt reported the uf pump was calibrated as a precaution, however the uf discrepancy was likely caused by operator error. The 2008t hemodialysis system has been returned to service and is fully operational. Approximately twenty minutes after completing treatment, the patient was conversing with another patient in the clinic when they became lightheaded and fell (despite utilizing a walker). The patient was assisted to their feet and stated they felt fine. However, once the patient exited the building heading to the transport vehicle, it was reported that the patient was unable to bear weight (specifics not provided) on the hip. The patient was transported to the emergency room (er) for evaluation, and radiological testing revealed they sustained a minor hip fracture. Per the rn, the patient had recently been discharged from a nursing facility (dates/specifics not provided). The rn stated the patient's blood pressure was ¿normal¿ after the fall, however it was unknown if hd therapy caused or contributed to the lightheadedness or fall.
 
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Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
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 Key9903679
MDR Text Key186519608
Report Number2937457-2020-00564
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
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 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190766
Device Catalogue Number190766
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 Received03/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2016
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: 03/31/2020 Patient Sequence Number: 1
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