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

Catalog Number 190305

Device Problems Mechanical Problem (1384); Reflux within Device (1522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill in recirculation mode, during set-up for use.There was no patient involvement associated with the event.The biomed did not report that there were any machine alarms.Multiple attempts were made to contact the biomed and obtain additional information.Thus far, those attempts have proven unsuccessful.It is unknown if any parts were replaced and/or if they are available to be returned for physical evaluation.

Manufacturer Narrative

Correction: e3 was inadvertently omitted from initial report.

Event Description

A biomedical technician (biomed) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill in recirculation mode, during set-up for use.There was no patient involvement associated with the event.The biomed did not report that there were any machine alarms.Multiple attempts were made to contact the biomed and obtain additional information.Thus far, those attempts have proven unsuccessful.It is unknown if any parts were replaced and/or if they are available to be returned for physical evaluation.

• 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; 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14000250
• MDR Text Key: 289530092
• Report Number: 2937457-2022-00571
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 190305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2002
• 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