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

Model Number 191130

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) requested an onsite service evaluation for a fresenius 2008t hemodialysis (hd) machine that was reportedly taking off fluid fast, had fluctuating transmembrane pressure (tmp), and failed the online pressure holding test (pht).A fresenius field service technician (fst) was dispatched to the facility to inspect the 2008t machine.The fst found that valve 36 was failing several times during the valve leak test.The fst also confirmed the machine failed the online pht and had fluctuating tmp.The fst replaced the dialysate pressure transducer to address the fluctuating tmp and ordered a new valve 36 for the facility.Upon follow-up, the fst stated that a nurse from the facility alleged that the machine was ¿taking off fluid too fast¿.The fst confirmed there had been no missed treatments, and the machine was confirmed to be removing the correct amount of fluid from patients.In addition, the fst confirmed the uf pump looked good and did not need calibrating.They also confirmed that valve 36 on the balancing chamber was leaking and the tmp was fluctuating up and down.As previously reported, the fst replaced the dialysate pressure transducer and valve 36.Upon completion of the repair, the machine passed all functional testing and was returned to service.There was no patient injury or harm due to the machine allegedly removing fluid too fast, a failure the fst could not confirm.The replaced parts were available to be returned for evaluation and the fst stated they would be returned via returned goods authorization (rga).

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility biomedical technician (biomed) requested an onsite service evaluation for a fresenius 2008t hemodialysis (hd) machine that was reportedly taking off fluid fast, had fluctuating transmembrane pressure (tmp), and failed the online pressure holding test (pht).A fresenius field service technician (fst) was dispatched to the facility to inspect the 2008t machine.The fst found that valve 36 was failing several times during the valve leak test.The fst also confirmed the machine failed the online pht and had fluctuating tmp.The fst replaced the dialysate pressure transducer to address the fluctuating tmp and ordered a new valve 36 for the facility.Upon follow-up, the fst stated that a nurse from the facility alleged that the machine was ¿taking off fluid too fast¿.The fst confirmed there had been no missed treatments, and the machine was confirmed to be removing the correct amount of fluid from patients.In addition, the fst confirmed the uf pump looked good and did not need calibrating.They also confirmed that valve 36 on the balancing chamber was leaking and the tmp was fluctuating up and down.As previously reported, the fst replaced the dialysate pressure transducer and valve 36.Upon completion of the repair, the machine passed all functional testing and was returned to service.There was no patient injury or harm due to the machine allegedly removing fluid too fast, a failure the fst could not confirm.The replaced parts were available to be returned for evaluation and the fst stated they would be returned via returned goods authorization (rga).

Manufacturer Narrative

Additional information: h3 plant investigation: although it was reported that a sample would be returned to the manufacturer for physical evaluation, to date no parts have been received.However, an onsite evaluation was performed by a fresenius field service technician (fst).The allegation of the uf failure was that the machine removed fluid too fast, and the fst was unable to confirm this.During testing, the fst found no issues with the uf pump and the uf pump did not need calibrating.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-conformance's, 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 fst was able to confirm that the machine failed the online pressure holding test (pht).They also confirmed that valve 36 on the balancing chamber was leaking and the transmembrane pressure (tmp) was fluctuating.However, the investigation into the cause of the reported uf problem was not able to be confirmed.Should a sample be returned at a later date, a supplemental report will be submitted capturing the updated investigation results.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13098363
• MDR Text Key: 284457619
• Report Number: 2937457-2021-02521
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• 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: 01/28/2022

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 Number: 191130
• Device Catalogue Number: 191130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1