MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	190895
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT CDX
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 12485762
• Report Number: 2937457-2021-01917
• Device Sequence Number: 17157833
• Product Code: KPO
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• PMA/510(K) Number: K121341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 190895
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS BLOODLINES; FRESENIUS DIALYZER
• Patient Age: 69 YR