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

Catalog Number 190713

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem Cramp(s) (2193)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between hd therapy on the 2008t machine and the patient symptoms of cramps and lightheadedness as the event occurred during treatment.However, there is no documentation in the complaint file to show any causal relationship between the adverse event and the 2008t machine.Additionally, the initial allegation of excess fluid being removed from the patient was later deemed an error by confused staff members as the patient¿s end weight was within the expected parameters.The machine was evaluated and passed all functional tests and was put back into service.Cramps during hemodialysis treatment are common in dialysis patients.Based on the available information the etiology of the cramps and lightheadedness are not confirmed; however, it is unlikely that the 2008t machine was the cause of the event.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.It was confirmed that the machine was inspected by a biomedical technician at the clinic, and it passed functional tests to return to service with no parts replaced or machine repairs made.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.

Event Description

A user facility clinic manager reported a fresenius 2008t machine that allegedly removed additional fluid from a patient during their treatment.Upon follow up with the clinic manager, it was discovered that the fluid removal issue was likely due to confusion on the part of the clinic staff, as the patient¿s pre and post weights were within the expected range.The clinic manager advised that three hours into the patient¿s treatment, they complained of cramping, and were administered 300ml of normal saline intravenously.The patient completed treatment on the machine, and had continued with their normally scheduled hemodialysis treatments without further issues.The machine was inspected by a biomedical technician at the clinic, and it passed functional tests to return to service with no parts replaced or machine repairs made.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7940329
• MDR Text Key: 123054441
• Report Number: 2937457-2018-02967
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 81