MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

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

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.This event is two of two for the same patient on two separate treatments on (b)(6) 2017.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient was dialyzing and coded during treatment on (b)(6) 2017.It was unknown if the patient was able to complete hemodialysis treatment.No reported problems were reported with the machine during treatment, and the staff stated that they did not think there was a problem with the machine.Per biomed tech no information about the patient of the incident was available other than the patient showed stroke like symptoms and coded.It was unknown if the patient was sent to the hospital.When checking the machine before returning to service it gave constant air detector alarm messages.They did not give audible alarms because the dialysate lines were on the shunt.Additional information was requested and was not received to date.

Manufacturer Narrative

Occupation: health care professional removed."a supplemental medwatch report will be submitted upon completion of the investigation." the investigation was complete when filed and no additional information is needed to be reported.

Event Description

A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient was dialyzing and coded during treatment on (b)(6) 2017.It was unknown if the patient was able to complete hemodialysis treatment.No reported problems were reported with the machine during treatment, and the staff stated that they did not think there was a problem with the machine.Per biomed tech no information about the patient of the incident was available other than the patient showed stroke like symptoms and coded.It was unknown if the patient was sent to the hospital.When checking the machine before returning to service it gave constant air detector alarm messages.They did not give audible alarms because the dialysate lines were on the shunt.Additional information was requested and was not received to date.

• Brand Name: 2008K2
• 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: 6965673
• MDR Text Key: 89855997
• Report Number: 2937457-2017-01060
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2010
• 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): Life Threatening; Required Intervention