MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS, _.2; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190731

Device Problems Calibration Problem (2890); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A fresenius regional equipment specialist (res) was called onsite to repair a 2008k hemodialysis (hd) machine with ultrafiltration (uf) pump out of specification.It was reported a hemodialysis (hd) patient coded while receiving treatment on the machine.The res recalibrated the uf pump to resolve the issue.The machine was returned to service.Follow-up was made with the facility registered nurse (rn), who stated she was unwilling to disclose any patient information due to patient privacy/confidentiality.The rn stated the machine did not have any issues during set-up and that the machine did not alarm at the time the patient expired.The rn stated the facility used fresenius dialyzers, bloodlines, acid concentrate and bicarb concentrate delivered via jugs.The catalog and lot numbers of the fresenius products were unknown.No samples were obtained to be returned for evaluation.Although requested, no further patient specific or event related details were made available.

Manufacturer Narrative

(b)(6).Although there is an allegation against the fresenius 2008-k machine pulling too much fluid during treatment, any causality between the 2008-k machine or any fresenius products and the adverse event of cardiac arrest cannot be determined based on the lack of information provided.Additional information related to the patient¿s demographics, treatment data, medical interventions and hospitalization is needed to determine potential causality.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance during the manufacturing process.During repair it was found that the ultrafiltration (uf) pump was 15ml out of specification.A fresenius regional equipment specialist (res) technician calibrated the uf pump and the machine has been returned to service.No components were replaced during the repair.The record review confirmed the labeling, material, and process controls were within specification.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.There were no reported device malfunctions that would have caused the reported event.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.On (b)(6) 2017 it was reported by a regional equipment specialist (res) that a 2008k machine ultrafiltration (uf) pump was not removing the proper amount of fluid during a hemodialysis (hd) treatment while the patient was hospitalized.Based on the information captured in the file this patient with end stage renal disease (esrd) on hd for renal replacement therapy (rrt) ¿coded¿ while receiving treatment on (b)(6) 2017 (time, patient/treatment data, vital signs and hospital course unknown).During a follow up call to the hemodialysis registered nurse (hdrn) on (b)(6) 2017 it was reported ¿the machine did not alarm at the time the patient coded,¿ (time unknown) nor did the machine have any issues during set-up.The hdrn additionally stated that she was unwilling to disclose any patient information.On (b)(6) 2017 the machine was taken out-of-service post event to perform functional testing.During the functional testing the machine encountered an uf pump error once during a one (1) hour period of testing.Machine testing revealed the machine was removing 25 ml over the entered uf amount 1000 ml, or 15 ml greater than maximum allowable error limit.Uf pump was recalibrated and returned to service (date unknown).

Manufacturer Narrative

Correction: initial reporter occupation, pma/510k; the pma/510k date in the initial was submitted as ni, the correct pma/510k date is 2017-09-01.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS, _.2
• 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: 6905033
• MDR Text Key: 87794296
• Report Number: 2937457-2017-00978
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100866
• UDI-Public: 00840861100866
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2007
• 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): Hospitalization; Life Threatening; Required Intervention