MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 OLC ONLY WITH HEPARIN PUMP; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190628

Device Problem Temperature Problem (3022)

Patient Problem Vomiting (2144)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician reported a fresenius 2008k2 machine with a high temperature during treatment.The patient began to vomit and was unable to complete treatment.The patient was removed from the machine after 12 minutes of treatment.There was no blood loss reported, and the patient was hospitalized for observation.The biomedical technician advised the machine passed the self-test repeatedly after the patient was removed, but they were not able to calibrate the temperature until the ntc2 was replaced, which resolved the temperature issues.Additional patient and treatment information was not provided.

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.Clinical investigation: there is a temporal relationship between hemodialysis with the 2008k2 and the vomiting episode that resulted in the patient being sent to the hospital for observation.However, with the limited available information, it is not possible to determine the cause of the nausea and vomiting during hemodialysis.

• Brand Name: 2008K2 OLC ONLY WITH HEPARIN PUMP
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7677032
• MDR Text Key: 113634127
• Report Number: 2937457-2018-01924
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190628
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1