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

Model Number 190713

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem Cramp(s) (2193)

Event Date 09/01/2020

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 user facility biomedical technician (biomed) reported that the floor staff pulled a machine claiming that the ultrafiltration (uf) turned itself back on after turning it off, it stayed off after turning off a second time and wanted to know if there was any way of testing it to rule out operator error.Patient completed treatment without incident.Upon follow-up, the biomed stated the patient was cramping which was the reason that the uf was turned off.The uf turned off about 15 minutes into the patient's hemodialysis (hd) treatment.There were no machine alarms.The biomed confirmed that despite the cramping, there were no additional symptoms, injury, adverse event, medical intervention, and no additional treatments required as a result of the reported event.The patient was able to complete treatment on the same machine without issue.It was unknown if the correct uf goal was met, however the patient's pre and post treatment weights were as expected and the same scale was used for both treatments.It was confirmed that the patient did not eat or drink at all during treatment and no extra fluids were provided to the patient.The biomed confirmed that the machine was returned to service and no repairs or replacements were needed, and therefore no parts are available for return.The machine is back in service without reoccurrence of the reported event.Additional patient and treatment details were requested but reported to be unavailable.

Manufacturer Narrative

Additional information: h10 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.

• 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: 10555608
• MDR Text Key: 207590588
• Report Number: 2937457-2020-01693
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

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: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES.; FRESENIUS DIALYZER.; FRESENIUS BLOODLINES; FRESENIUS DIALYZER