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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
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CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) Back to Search Results
Model Number 190895
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
A fresenius regional sales manager reported that a dialyzer blood leak was observed after the completion of the patient¿s hemodialysis (hd) treatment.Upon follow up, it was reported that the blood leak was internal and visually observed on the hansen connector tubing after the patient¿s treatment was successfully completed.The machine, a fresenius 2008t machine, did not alarm for a blood leak during treatment.Blood leak test strips were not used to confirm the observed blood.There was no estimated blood loss (ebl) reported, nor any patient injury, adverse events, or medical intervention required as a result of this event.The patient completed treatment successfully on the same machine with the same supplies.The dialyzer sample was discarded.
 
Manufacturer Narrative
Corrected information: g2 plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
A fresenius regional sales manager reported that a dialyzer blood leak was observed after the completion of the patient¿s hemodialysis (hd) treatment.Upon follow up, it was reported that the blood leak was internal and visually observed on the hansen connector tubing after the patient¿s treatment was successfully completed.The machine, a fresenius 2008t machine, did not alarm for a blood leak during treatment.Blood leak test strips were not used to confirm the observed blood.There was no estimated blood loss (ebl) reported, nor any patient injury, adverse events, or medical intervention required as a result of this event.The patient completed treatment successfully on the same machine with the same supplies.The dialyzer sample was discarded.
 
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Brand Name
2008T GEN 2 BIBAG WITHOUT CDX
Type of Device
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
MDR Report Key12485762
MDR Text Key271890815
Report Number2937457-2021-01917
Device Sequence Number1
Product Code KPO
UDI-Device Identifier00840861100927
UDI-Public00840861100927
Combination Product (y/n)N
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number190895
Device Catalogue Number190895
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 09/09/2021
Initial Date FDA Received09/16/2021
Supplement Dates Manufacturer Received09/28/2021
Supplement Dates FDA Received10/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS BLOODLINES; FRESENIUS DIALYZER
Patient Age69 YR
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