BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ SS W/SINGLE PATIENT BODY CONN

    MDR report key: 4121231 · Received September 23, 2014

    Report

    Report Number
    8030665-2014-00752
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 25, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE, REYNOSA MANUFACTURING
    Product Code
    KDJ
    PMA / PMN Number
    K904806
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE CLINICAL INVESTIGATION OF THE AVAILABLE MEDICAL RECORDS AND THE PLANT'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE MANUFACTURER WITH THE LOT NUMBER OF THE PRODUCT USED IN THE REPORTED EVENT AS NO LOT NUMBER WAS PROVIDED BY THE COMPLAINANT, A RECORD REVIEW WAS PERFORMED ON EACH OF THE LOT NUMBERS SHIPPED TO THE COMPLAINANT IN THE THREE MONTHS LEADING UP TO THE REPORTED EVENT. THE RECORD REVIEW FOUND 3 LOT NUMBERS SHIPPED TO THE CUSTOMER DURING THAT TIME PERIOD. THE BATCH PRODUCTION RECORDS FOR THESE LOTS WERE REVIEWED. THE BATCH RECORDS CONFIRMED THAT RELEASED PRODUCT MET SPECIFICATIONS, AND DOCUMENTED MANUFACTURING PROCESS CONTROLS WERE WITHIN SPECIFICATION. PER THE DOCUMENTED PRODUCT INVESTIGATION, THERE WAS NO INDICATION THAT THE FRESENIUS PRODUCT CAUSED, CONTRIBUTED TO OR WAS A FACTOR IN THE REPORTED EVENT. ONE CASE OF COMPANION SAMPLES FROM ONE OF THE POTENTIAL LOTS WAS RECEIVED ON 09/24/2014 FROM PRODUCT LINE 050-87211 LOT NUMBER 14AR08147, A VISUAL INSPECTION WAS PERFORMED ON FOUR TUBING SETS AND NO DEFECTS OR ISSUES WERE FOUND. THE TUBING SETS WERE FOUND ACCEPTABLE AS PER BOM NO 050-87211. THE COMPLAINT WAS DEEMED AS NOT CONFIRMED, THE COMPANION SAMPLES DID NOT SHOW ANY ISSUE DURING EVALUATION.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS DEEMED AS NOT CONFIRMED, THE COMPANION SAMPLES DID NOT SHOW ANY ISSUE DURING EVALUATION. ONE CASE OF COMPANION SAMPLES WAS RECEIVED ON 09/24/2014 FROM PRODUCT LINE 050-87211 LOT NUMBER 14AR08147, A VISUAL INSPECTION WAS PERFORMED ON FOUR TUBING SETS AND NO DEFECTS OR ISSUES WERE FOUND. THE TUBING SETS WERE FOUND ACCEPTABLE AS PER BOM NO (B)(4). THE COMPLAINT WAS DEEMED AS NOT CONFIRMED; THE COMPANION SAMPLES DID NOT SHOW ANY ISSUE DURING EVAL. BASED ON THE MEDICAL RECORDS - SHORTNESS OF BREATH, AND PERITONITIS, WHICH HAD BEEN REPORTED AS A SERIOUS INJURY ARE NOT CONCLUSIVELY RELATED TO PD TREATMENT. THE PATIENT ALSO IS PENDING FURTHER CARDIAC WORK UP RULING OUT AN ANTERIOR INFARCT; HOWEVER, THERE WAS NO REPORT OF MALFUNCTION OF LIBERTY CYCLER SYSTEM BEING OUT OF SPECIFICATIONS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PT WAS HOSPITALIZED. THE FOLLOWING IS FROM THE MEDICAL RECORDS PROVIDED BY THE PT'S TREATMENT FACILITY. THE PATIENT PRESENTED WITH A ONE DAY HISTORY OF ABDOMINAL PAIN. SHE WAS TREATED WITH VANCOMYCIN. SHE ALSO COMPLICATED OF SHORTNESS OF BREATH DURING BOTH EXERTION AND AT REST. SHE ALSO STATED THAT SHE HAD ORTHOPNEA, WHICH IMPROVED WHEN SHE SAT UPRIGHT. THE PT REPORTED FEELING WEAK AND TIRED FOR THE PAST TWO DAYS IN ADDITION TO HAVING DIAPHORESIS, NAUSEA, VOMITING ONCE THE CHILLS. THE PT WAS DIAGNOSED WITH PERITONITIS AND TREATED WITH TWO GRAMS OF VANCOMYCIN DELIVERED VIA INTRA-PERITONEAL ACCESS EVERY THREE DAYS FOR FIVE WEEKS AND WITH ONE RAM OF CEFTAZIDIME FOR TEN DAYS. SHE WAS DISCHARGED ON (B)(6) 2014. PER PD NURSE, THE PT HAS BEEN ABLE TO CONTINUE THE CYCLER-BASED PERITONEAL DIALYSIS TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591224 NEWTON IQ SS W/SINGLE PATIENT BODY CONN KDJ FRESENIUS MEDICAL CARE, REYNOSA MANUFACTURING UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R ELPHOROV| METOCLOPROMIDE| AMLODIPINE| DELFLEX PD SOLUTIONS| REQUIP| SENSIPAR| VITAMIN D| RENVELA| REGLAN| POSTASSIUM CHLORIDE| MAGNEBIND| HYDROCODONE ACETAMINOPHEN| NPH INSULIN| GENTAMICIN| GABAPENTIN| EPOGEN| DOCUSATE SODIUM| CALCITROL| LISINOPRIL| FUREOSEMIDE| LEVOTHYROXINE| SIMVASTATIN