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

Model Number 2008K

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

Patient Problem Edema (1820)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Patient (who is currently receiving peritoneal dialysis treatments) medical records received on an unrelated customer experience indicated that the patient was diagnosed and treated for a pulmonary edema on an unknown date.Follow-up with the patient's nurse indicated that the alleged event occurred sometime in 2016.The patient was receiving dialysis treatment at an in-center dialysis clinic at the time.Additional information was solicited.

Manufacturer Narrative

Based on the available information, there is no allegation or documentation that indicates the 2008 k machine caused or contributed to the patient¿s pulmonary edema event.The alleged event was not confirmed by the manufacturing plant.The device was not returned to the plant for investigation.A device history review could not be performed since the lot number is unknown.

• Brand Name: 2008K MACHINE
• 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: 7142390
• MDR Text Key: 95633951
• Report Number: 2937457-2017-01401
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2008K
• Device Catalogue Number: UNKNOWN- 2008K MACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/02/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR