MAUDE Adverse Event Report: CONCORD MANUFACTURING FRESENIUS 2008K MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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

Patient Problem Unspecified Infection (1930)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis. Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event. However, no malfunction of the 2008k hemodialysis (hd) machine was alleged, observed, or identified by the user facility during the patient's final hd treatment. An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the 2008k hemodialysis (hd) machine in question was not known, therefore, the serial number was not able to be provided. However, all device history records (dhr) are reviewed and released according to the "dhr review checklist & release procedure. " p/n 500658; a device is not released if it does not meet requirements or is nonconforming. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

Event Description

A registered nurse at a user facility reported to post market surveillance that a patient experienced an infection while undergoing hemodialysis (hd) therapy at a hospital. Additional information has been requested, but has not been made available. There was no allegation that a machine, a dialyzer or bloodline malfunction occurred. No parts were available to be returned to the manufacturer for evaluation.

• Brand Name: FRESENIUS 2008K MACHINE
• 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: 6773185
• MDR Text Key: 250379090
• Report Number: 2937457-2017-00696
• Device Sequence Number: 1
• Product Code: KDI
• 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: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 08/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/08/2017 Patient Sequence Number: 1

Treatment

UNKNOWN BLOODLINES; UNKNOWN DIALYZER