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 10/04/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   a temporal relationship exists between hd therapy utilizing the 2008k2 hemodialysis system, and the adverse event of cardiac arrest. Although the patient was connected to the 2008k2 hemodialysis system when the event occurred, there is no allegation indicating a fresenius product deficiency or malfunction caused or contributed to the patient¿s cardiac arrest. The occurrence of a cardiac arrest in hd patients is low considering the complex nature of the procedure. However, given the results of the functional compliance testing and the absence of treatment records and/or hospitalization summary; the 2008k2 hemodialysis system cannot be excluded from having a possible causal or contributory role in the patient¿s cardiac arrest, as there is insufficient evidence to conclude causality.

Event Description

It was reported that a patient undergoing hemodialysis (hd) for renal replacement therapy coded during treatment. Follow-up with the inpatient program manager (ipm) confirmed the patient suffered a cardiac arrest and coded during hd therapy (specifics not provided). Additional information was requested (e. G. Treatment records, past medical history, concomitant medications and patient demographics), however the ipm declined the request. Functional compliance testing was ordered for the 2008k2 hemodialysis system following the event. A regional equipment specialist performed testing on the machine. The ultrafiltration (uf) pump strokes were elevated and out of range. The pumps were recalibrated. The machine completed operation verification. The machine was not returned to the manufacturer for evaluation.

• 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 ; 7816999758
• MDR Report Key: 9187065
• MDR Text Key: 162286819
• Report Number: 2937457-2019-03168
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• 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?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2010
• 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: 10/14/2019 Patient Sequence Number: 1