MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K@HOME MACHINE, SHORT CAB, OLC/DP, HP

Model Number K@HOME

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

Patient Problem Blood Loss (2597)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

The user facility reported that one of their home patient's had experienced an a24 alarm during treatment and was unable to continue with the treatment.The blood pump had stopped and the patient's blood was not returned as the patient did not want to do it manually.There was no medical intervention or ill effects associated with this incident.

Manufacturer Narrative

The investigation is currently pending; a supplemental mdr will be submitted, upon completion of the device investigation.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The machine was repaired by a biomed who reported that the a24 alarm was resolved by replacing the blood pump module.The machine was returned to service with no further issues.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: 2008K@HOME MACHINE, SHORT CAB, OLC/DP, HP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; concord plant; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: corie vazquez ; 920 winter st.; waltham, MA 02451-1457 ; 7816999071
• MDR Report Key: 4745095
• MDR Text Key: 21062092
• Report Number: 2937457-2015-00801
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: K@HOME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• 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