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

Model Number 191128

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

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008t hemodialysis (hd) machine had a saline bag backfill that occurred during testing.The biomed was performing troubleshooting on the machine when it occurred.The biomed said the original problem was that the machine was giving a ¿system leak, can¿t run¿ message during bleach disinfect.The machine was also giving a ¿flow inlet error¿ in rinse mode.The biomed told ts that they had replaced the heat exchanger.The biomed confirmed the ¿air pump¿ and ¿flow pump¿ were both calibrated and rebuilt, and the water inlet pressure was calibrated.After doing this, the bicarb pump would not run.However, when the biomed plugged the acid into the bicarb pump, they said that it worked.They ordered a new distribution board because they thought the one in the machine was bad.The biomed confirmed visually seeing the saline bag refilling with fluid.They were unsure if the machine had the cbe upgrades.The biomed confirmed there were no filling program errors.They said there was "nothing wrong with the drain line" when asked if it was within the length and height specification.They also said there were no quick disconnects being used.The biomed indicated that user error was not in play and stated that a clamp was not being used.The biomed confirmed there was no patient involvement associated with the reported event.The machine is still out of service.If replacing the distribution board does not resolve the reported problems, the biomed said they would contact ts for further assistance and request onsite service.No further details were available upon follow up.

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 HD SYS. W/O CDX 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15879835
• MDR Text Key: 305735863
• Report Number: 0002937457-2022-02068
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/29/2022

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: Other
• Device Model Number: 191128
• Device Catalogue Number: 191128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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