MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

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

Patient Problem Cardiac Arrest (1762)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed. There is a temporal relationship between hd therapy on the 2008k2 machine and the patient event of cardiac arrest as the patient was in active treatment at the time. However, there is no documentation in the file to show a causal relationship. Additionally, there is no allegation of a machine malfunction or deficiency related to this event. The patient was in the icu and very unstable prior to initiation of treatment. There were no issues documented with the machine or the treatment. Although the patient was resuscitated, she remains in the icu and has not continued with renal replacement therapy. The facility does not require a manufacturer machine evaluation to be completed. Based on the available information the 2008k2 machine can be excluded as the cause of the patient¿s adverse event. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility's biomedical technician (bmt) reported to technical support that a patient coded on a 2008k hemodialysis system. Upon follow-up with the hd nurse, the patient was in the intensive care unit (icu) for undisclosed reasons. The patient was very unstable prior to initiation of hd treatment on (b)(6) 2019 utilizing the fresenius 2008k2 hd machine. During the treatment (time unknown), the patient coded. The patient was resuscitated (details not provided) and the treatment was not completed. The patient remains in the icu, however, has not continued with renal replacement therapy since the event. There were no machine issues during the treatment and the machine did not require evaluation by a fresenius regional equipment specialist. No further information could be provided.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 8669882
• MDR Text Key: 147029689
• Report Number: 2937457-2019-01782
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 190610
• 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: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• 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: 06/05/2019 Patient Sequence Number: 1