BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 4112615 · Received September 10, 2014

    Report

    Report Number
    1225714-2014-11142
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 1, 2012
    Report Date
    January 29, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. THERE WAS NO INDICATION THAT A FMC DEVICE MALFUNCTIONED OR CAUSED A SERIOUS INJURY. THE INVESTIGATION OF THE FMC CONCENTRATE DEVICE, INCLUDING REVIEW OF THE DEVICE HISTORY RECORD, AND LABELING EVAL REVEALED NO DEVIATIONS OR NON-CONFORMANCES. THE REPORTED DEVICE RELATED EVENT IS UNCONFIRMED. A CLINICAL INVESTIGATION INDICATES A CARE MANAGEMENT PROBLEM BETWEEN THE PT AND THE CARE TEAM. THE FMC PHARMACOVIGILANCE PHYSICIAN CONCLUDES THE ALLEGATIONS ARE NOT CONSISTENT WITH THE OCCURRENCE OF A SERIOUS INJURY; FROM THE NARRATIVE OF THE CUSTOMER, IT APPEARS AS IF THE PT HAS PROBLEMS MANAGING INTERDIALYTIC FLUID INTAKE. THERE IS NO HISTORY OF DEVICE MALFUNCTION, HYPOKALEMIA, METABOLIC ALKALOSIS, OR SERIOUS INJURY. THIS IS A RETROSPECTIVE MDR BEING SUBMITTED BY FRESENIUS MEDICAL CARE AS A REMEDIATION ACTION COMMITTED TO FDA REGARDING ALL POTENTIAL ADVERSE EVENTS RECEIVED BETWEEN 03/21/2011 TO 03/11/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PT FAMILY MEMBER, THE PT (RELATIVE OF THE REPORTER) WAS RETURNED FROM THE DIALYSIS TREATMENT CTR WITHOUT HAVING RECEIVED DIALYSIS TREATMENT. HE WAS TAKEN TO THE HOSP FOR TREATMENT. THE HOSP DID NOT PROVIDE DIALYSIS TREATMENT. THE REPORTER ALLEGES THE CARE AT THE DIALYSIS TREATMENT CTR IS IMPROPER/INSUFFICIENT. THE REPORTER STATED THE PT, "...WAS GIVEN GRANUFLO, WHICH CAUSES HEART ATTACKS AND STROKES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559528 GRANUFLO DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other