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

Catalog Number UNKNOWN- 2008T MACHINE

Device Problem Inadequate Ultra Filtration (1656)

Patient Problems Edema (1820); Headache (1880); Low Blood Pressure/ Hypotension (1914); Swelling/ Edema (4577)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a hemodialysis (hd) patient is constantly having issues (exact dates, occurrences not provided) with how much fluid the clinic staff does or does not remove during treatment. The patient does not like too much fluid removed as they do not feel well after with headaches. The staff has a hard time controlling the patient's blood pressure (bp) during treatment. The bp drops low so then they need to administer fluids to counter the bp issue. The hd nurse said it is a constant balancing act to keep the correct amount of fluid off without giving the patient symptoms and without leaving too much fluid on. The hd nurse stated the patient is non-compliant with diet and medication. The patient always comes to treatment with signs of edema in their legs and abdomen and with swollen eyelids. The patient does not have have any fluid in their lungs. The patient admits to drinking too much over the weekend and between treatments. The nurse practitioner prescribed the patient midodrine for the low bp which the patient is refusing to take until they see their primary care physician.

• Brand Name: 2008T MACHINE
• 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: 11396997
• MDR Text Key: 234202210
• Report Number: 2937457-2021-00341
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• 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: 03/09/2021
• 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