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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 191130
Device Problem No Audible Alarm (1019)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/04/2024
Event Type  malfunction  
Event Description
A field service technician (fst) reported finding blood in and around the blue dialyzer connector during a routine patient check (performed every 15 minutes per customer policy).The machine did not alarm or show a blood leak.It is unclear how much blood made it into the machine or how quickly it was discovered.It is possible that the routine check caught the issue before the machine alarmed.There was no harm to patient, treatment was resumed on a backup unit.The machine passed self-tests and the chemical disinfect (bleach) program was run multiple times by the staff following the incident.The fst reviewed the current blood leak detector voltages, then calibrated the blood leak detector and stated the machine was good for use.The estimated blood loss was unknown.Additional information was requested but was not received to date.
 
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.The field service technician investigation could not duplicate the reported problem; thus the complaint is unconfirmed.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.
 
Event Description
A field service technician (fst) reported finding blood in and around the blue dialyzer connector during a routine patient check (performed every 15 minutes per customer policy).The machine did not alarm or show a blood leak.It is unclear how much blood made it into the machine or how quickly it was discovered.It is possible that the routine check caught the issue before the machine alarmed.There was no harm to patient, treatment was resumed on a backup unit.The machine passed self-tests and the chemical disinfect (bleach) program was run multiple times by the staff following the incident.The fst reviewed the current blood leak detector voltages, then calibrated the blood leak detector and stated the machine was good for use.The estimated blood loss was unknown.Additional information was requested but was not received to date.
 
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Brand Name
2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
Type of Device
DIALYZER, 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key18532747
MDR Text Key333216099
Report Number0002937457-2024-00097
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102112
UDI-Public00840861102112
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number191130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received02/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER
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