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

Model Number 2008K OLC ONLY WITH HEPARIN PUMP

Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/23/2016

Event Type  malfunction  

Manufacturer Narrative

Investigations findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and not during dialysis mode.The user visually observed the saline bag refilling with dialysate during circulation.There have been no adverse events associated with the reported issue.The report is being investigated by the manufacturer via a capa.Plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

A facility biomedical technician (biomed) reported that a saline bag back filled while the unit was serviced.The machine was giving alternating alarm messages of tmp and filling program at the time of the event.There were no audible alarms because the audible alarms (when lines off shunt) option was turned off in service mode.The biomed was not able to confirm if the tmp alarm messages were high or low or what the value was.Most current software upgrades had not been completed on this machine at the time of the event.Follow-up information provided by the biomed revealed that the air separator was replaced which resolved the issue.The unit has been returned to service at the user facility without a recurrence of the reported issue.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.Follow-up provided by the biomed revealed that the air separator was replaced which resolved the issue.The unit has been returned to service at the user facility without a recurrence of the reported issue.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 deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: 2008K 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
• 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: 6239124
• MDR Text Key: 64433389
• Report Number: 2937457-2017-00023
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 2008K OLC ONLY WITH HEPARIN PUMP
• Device Catalogue Number: 190305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0629-2014
• Patient Sequence Number: 1
• Treatment: UNKNOWN SALINE (DISCARDED-NOT USED)