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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); No Information (3190)

Event Date 07/16/2020

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: minimal information was provided regarding the event.The adverse event resulted in the patient being removed from the machine prior to the end of treatment.There were no machine symptoms or problems when the patient experienced the adverse event.There is no information reporting that the event resulted in any medical intervention.There is no report that the adverse event was related to use of the hemodialysis machine or treatment.It was reported that the patient has since expired since the reported event, however; the patient was not in treatment at the time of death and there was no allegation that the death was related to the adverse event or use of the 2008t machine.The 2008t machine rotor was replaced, and the machine was put back into service.The charge nurse could not confirm the information provided by the biomed and did not have access to any patient information or recall any adverse event that occurred to any patient under their care while on duty during the reported event date.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product.

Event Description

A user facility biomedical technician (biomed) reported that the rotor pin on a hemodialysis (hd) machine was protruding, but was not causing any scaping damage to the blood pump plate.It was reported that the issue was found during machine inspection.It was reported that the machine was rejected due to an adverse patient event that occurred while the patient was in treatment (specific details not provided).It was reported that the machine had no problems while the patient experienced the adverse event.Upon follow-up with the biomed, it was reported that the patient since passed away.No specific information could be provided in regards to the patient's adverse event and subsequent expiration, however it was stated that the patient was not undergoing hd treatment at the time of passing.The biomed confirmed that the machine has approximately 1300 hours and that there were no other damaged parts.All the parts are the original fresenius parts on the machine.It was confirmed that the rotor was replaced and the machine is back in service.The damaged part was reported to be available for return to the manufacturer for evaluation.Additional information regarding the adverse event was requested from the facility charge nurse, but the information was unavailable.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional information: plant investigation: the blood pump rotor was returned to the manufacturing plant for evaluation.Inspection of the received blood pump rotor found no protruding pins or other discrepancies.The rotor pins were crimped.The reported issue could not be confirmed based on the returned product, as there is no indication that the part could have caused or contributed 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
• 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: 10364648
• MDR Text Key: 201609220
• Report Number: 2937457-2020-01392
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (y/n): N
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 191128
• Device Catalogue Number: 191128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Device Age: MO
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 11/10/2020
• Supplement Dates FDA Received: 08/18/2020; 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other