MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problems Mechanical Problem (1384); Reflux within Device (1522)

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

Event Date 07/19/2021

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 biomedical technician (bmt) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill.The bmt stated that a staff member visually observed the saline bag refilling with dialysate during the setup for a treatment.The bmt thought the air separator assembly was causing the issue, so he replaced the rotor and returned the machine to service.There have been no reoccurrences of the reported event and the bmt believes the issue has been resolved.The bmt confirmed there was no patient involvement as the incident occurred during setup.The bmt discarded the air separator assembly that was replaced; no sample available to be returned for evaluation.

Event Description

A biomedical technician (bmt) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill.The bmt stated that a staff member visually observed the saline bag refilling with dialysate during the setup for a treatment.The bmt thought the air separator assembly was causing the issue, so he replaced the rotor and returned the machine to service.There have been no reoccurrences of the reported event and the bmt believes the issue has been resolved.The bmt confirmed there was no patient involvement as the incident occurred during setup.The bmt discarded the air separator assembly that was replaced; no sample available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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
• MDR Report Key: 12213157
• MDR Text Key: 263205297
• Report Number: 2937457-2021-01541
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1