MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 191126

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

It was reported that a hemodialysis (hd) patient had sudden onset of chest pain during treatment and was taken to the hospital by ambulance where they were kept overnight for observation before being released. Functional testing of the machine revealed the ultrafiltration (uf) pump calibration was off despite the machine having recently undergone preventative maintenance (uf verification was 25. 1mm). Additional information was obtained through follow up with the hd clinic and treatment records received for 11/14/2019. This (b)(6)-year-old female acute kidney injury (aki) patient who started on hemodialysis (hd) on (b)(6) 2019 arrived at the clinic on (b)(6) 2019 for a scheduled 4-hour hd treatment. Pre-treatment vitals were blood pressure (bp) 142/87 (sitting), pulse 92 and regular, respirations 12 and temperature 97. 8° with a weight of (b)(6) kg (increase of 1. 3kg from last treatment on (b)(6) 2019). The patient was initiated on hd treatment with a tunneled central venous catheter (cvc) in the chest. The patient was utilizing the fresenius 2008t machine, optiflux 160nre dialyzer, 3. 0k, 2. 25ca, 1. 0mg, 100 dextrose dialysate. The treatment was set for blood flow rate 450 and dialysate flow rate auto 1. 5. The patient denied any complaints. Treatment started at 0647 hours. At 0836 hours the bp cuff required to be adjusted and total loss was decreased to (b)(6) kg. At 10:11am, 3 hours and 24 minutes into the 4-hour treatment, the patient was found unresponsive. The registered nurse was notified. The treatment was ended, the ultrafiltration (uf) turned off and blood was returned to the patient. 911 was called. The patient became responsive and complained of chest pain. The treatment record documented the patient as tachypneic and with dyspnea. The clinic administered 800ml of intravenous (iv) normal saline (ns), 1 nitroglycerin tab and oxygen (o2) at 4l via nasal cannula. The patient¿s bp was 96/64 and pulse 78. The last post-treatment vitals recorded bp sitting as 214/106, pulse 84 regular and respirations 16. The patient weight is recorded as (b)(6) kg for a total loss of (b)(6) kg. The patient was transported via emergency medical services (ems) to the local emergency room (er). The patient was not given any medical intervention at the er and they were admitted to the hospital overnight for observation (>24 hour stay). The hospital diagnosis was chest pain with no cause documented. The patient has returned to hd therapy with no additional issues encountered. The 2008t machine had annual preventative maintenance (pm) on 09/12/2019 with no issues noted. The machine has been evaluated by the clinic biomedical engineer and remains out of service. The clinic was provided instructions to repair the machine to be returned back in service. Clinical investigation: there is a temporal relationship between hd therapy on the 2008t machine with the patient event of tachypnea, dyspnea, chest pain and unresponsiveness with transport to the hospital. However, there is no documentation in the complaint file to show a causal relationship between the event and use of the 2008t machine. There are no issues with the ultrafiltration noted in the treatment record. The uf was not turned off until the patient event occurred. Although the patient was sent to the hospital after medical intervention in the hd clinic, no cause of the chest pain was determined, and no further intervention was required. The patient experienced a drop in their blood pressure prior to the event from 111/41 to 94/64 which can likely be classified as intradialytic hypotension. Intradialytic hypotension is a common complication of hemodialysis and fluid administration and oxygen is the usual treatment. Based on the available information, it cannot be confirmed if the reported ultrafiltration pump issue was related to the patient adverse event. Therefore, the 2008t machine cannot be excluded as causing or contributing to the patient adverse event.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 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: 9418866
• MDR Text Key: 169448118
• Report Number: 2937457-2019-03534
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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: 12/05/2019 Patient Sequence Number: 1