MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	191128
Medical Device Problem Code	Inadequate Ultra Filtration (1656)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility registered nurse (rn) reported upon completion of a patient's hemodialysis (hd) treatment the machine noted with an ultrafiltration (uf) rate at 70ml and the uf removed at 228 ml.A field service technician (fst) completed a uf problem identification checklist and could not duplicate the symptom.A simulated one hour treatment was performed with a 1000 ml goal.995ml was removed at end of the treatment clock when the test completed.Upon follow-up, the rn confirmed the reported event and stated the patient had an inadequate uf removal during their hemodialysis treatment.It was unknown what may have attributed to the reported issue.The rn stated the machine had been pulled from service and was evaluated by the fst, who was unable to duplicate the symptom.Per rn the patient did not require any medical intervention as a result of the reported issue and remained asymptomatic.It was decided by the nephrologist and agreed by the patient to return to the clinic the following day for additional hd treatment, which was completed without issue.The rn confirmed the patient had since been able to continue in-center hd therapy without further issue.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility registered nurse (rn) reported upon completion of a patient's hemodialysis (hd) treatment the machine noted with an ultrafiltration (uf) rate at 70ml and the uf removed at 228 ml.A field service technician (fst) completed a uf problem identification checklist and could not duplicate the symptom.A simulated one hour treatment was performed with a 1000 ml goal.995ml was removed at end of the treatment clock when the test completed.Upon follow-up, the rn confirmed the reported event and stated the patient had an inadequate uf removal during their hemodialysis treatment.It was unknown what may have attributed to the reported issue.The rn stated the machine had been pulled from service and was evaluated by the fst, who was unable to duplicate the symptom.Per rn the patient did not require any medical intervention as a result of the reported issue and remained asymptomatic.It was decided by the nephrologist and agreed by the patient to return to the clinic the following day for additional hd treatment, which was completed without issue.The rn confirmed the patient had since been able to continue in-center hd therapy without further issue.
Additional 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.

• Brand Name: 2008T HD SYS. W/O CDX BLUE STAR
• Common Device Name: 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 Key: 18470302
• Report Number: 0002937457-2024-00037
• Device Sequence Number: 6924528
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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 Catalogue Number: 191128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 100 KG