MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190618

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reported a fresenius 2008k2 machine that experienced issues due to a high flow error, blood pump stopping, and the uf pump shutting off.Event occurred during treatment while the patient was connected.Patient opted to complete treatment on a different machine, no blood loss was experienced.It was later confirmed that a fresenius (b)(4) technician cleaned carbon dust from the deaeration motor to resolve the issue and return the machine to service.Additional information was requested, but was not provided."alarma de flujo alto, se para bomba de sangre,se apaga ultrafiltracion en qué momento se originó la falla? durante tratamiento había paciente conectado cuando ocurrió el evento? sí hubo algún cambio en la salud del paciente? no ocurrió algún tipo de perdida de sangre? no canceló el tratamiento o pudo continuar? continuó en otro equipo el paciente fue trasladado a otro equipo o continuó en el mismo? se trasladó fue necesario utilizar nuevos consumibles, o se utilizaron los que se tenían en el equipo que presentó la falla? nuevos.".

Manufacturer Narrative

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

Event Description

Corrected event description: a customer reported a fresenius 2008k2 machine that experienced issues due to a high flow error, blood pump stopping, and the uf pump shutting off.Event occurred during treatment while the patient was connected.Patient opted to complete treatment on a different machine, no blood loss was experienced.It was later confirmed that a fresenius mexico technician cleaned carbon dust from the deaeration motor to resolve the issue and return the machine to service.Additional information was requested, but was not provided.

Manufacturer Narrative

Plant investigation: a fresenius mexico technician reportedly cleaned carbon dust from the de-aeration motor to resolve the issue and return the machine to service.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.

• Brand Name: 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH
• 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: 8159377
• MDR Text Key: 130541605
• Report Number: 2937457-2018-03659
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190618
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 12/14/2018; 12/20/2018
• Supplement Dates FDA Received: 12/17/2018; 12/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2012
• 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