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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN-2008K2; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING UNKNOWN-2008K2; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- 2008K2 MACHINE
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2022
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility clinical manager reported that an internal dialyzer blood leak occurred one hour after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that could be visually observed as streaks within the dialyzer.The machine, a fresenius 2008k2 machine, did not alarm with a blood leak alarm.Blood leak test strips were not used as the blood streaks were visually noted on the top of the dialyzer housing and treatment was discontinued.The patient's blood was not returned.There was no defect or damage noted on the dialyzer prior to use.Immediately following the event, the patient was re-setup with new supplies on the same machine where they were able to complete treatment.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient discontinued treatment after the blood leak occurred.The dialyzer was available to be returned for manufacturer evaluation.
 
Event Description
A user facility clinical manager reported that an internal dialyzer blood leak occurred one hour after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that could be visually observed as streaks within the dialyzer.The machine, a fresenius 2008k2 machine, did not alarm with a blood leak alarm.Blood leak test strips were not used as the blood streaks were visually noted on the top of the dialyzer housing and treatment was discontinued.The patient's blood was not returned.There was no defect or damage noted on the dialyzer prior to use.Immediately following the event, the patient was re-setup with new supplies on the same machine where they were able to complete treatment.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient discontinued treatment after the blood leak occurred.The dialyzer was available to be returned for manufacturer evaluation.
 
Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted. .
 
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Brand Name
UNKNOWN-2008K2
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 Key15218649
MDR Text Key305529437
Report Number0002937457-2022-01348
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 User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN- 2008K2 MACHINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received08/18/2022
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 Sequence Number1
Treatment
FRESENIUS 180NRE DIALYZER; FRESENIUS 180NRE DIALYZER; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
Patient Age80 YR
Patient SexMale
Patient Weight53 KG
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