BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 7.5FR. 40CC IAB

    MDR report key: 9948279 · Received April 10, 2020

    Report

    Report Number
    2248146-2020-00216
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    March 17, 2020
    Report Date
    June 16, 2020
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A - DATE OF BIRTH: FROM: [BLANK], TO: (B)(6) 1965. SECTION D - BRAND NAME: FROM: SENSATION PLUS 8FR. 50CC, TO: SENSATION PLUS 7.5FR. 40CC IAB. SECTION D - CATALOG #: FROM: 0684-00-0575, TO: 0684-00-0567. SECTION D - LOT #: FROM: (B)(6), TO: (B)(6). SECTION D - EXP. DATE: FROM: 12/19/2022, TO: 11/05/2022. SECTION H - MANUFACTURE DATE: FROM: 12/19/2019, TO:11/05/2019. THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED WITH BLOOD ON THE EXTERIOR AND INTERIOR OF THE CATHETER. THE SENSOR CABLE WAS RETURNED CUT AT APPROXIMATELY 6.35CM FORM THE REAR OF THE Y-FITTING. IN THE SAME MANNER, THE PRESSURE TUBING WAS ALSO RETURNED CUT AT APPROXIMATELY 7.9CM FROM THE FEMALE PORT. A CATHETER TUBING KINK WAS OBSERVED NEAR THE Y-FITTING AT APPROXIMATELY 76.7CM FROM THE IAB TIP. AT THIS SAME LOCATION, AN INNER LUMEN/OPTICAL FIBER BREAK WAS ALSO OBSERVED. AN UNDERWATER LEAK TEST OF THE BALLOON, Y-FITTING, CATHETER TUBING AND EXTRACORPOREAL TUBING WAS PERFORMED AND A LEAK WAS DETECTED AT THE INNER LUMEN BREAK LOCATION. THE EVALUATION CONFIRMED THE REPORTED LEAK WHICH APPEARS TO HAVE BEEN CAUSED BY A KINK ON THE INNER LUMEN WHICH DEVELOPED INTO A BREAK. HOWEVER, WE ARE UNABLE TO DETERMINE WHEN THIS MAY HAVE OCCURRED. A DEVICE AND LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. REFERENCE COMPLAINT #: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INITIAL REPORTER - (B)(6). ADDITIONAL EVENT SITE EMAIL - (B)(6). ADDITIONAL EVENT SITE TELEPHONE - (B)(6). OCCUPATION - RISK MANAGER. SEX - MALE. AGE AT THE TIME OF EVENT AND AGE UNITS(PATIENT) - 54. WEIGHT AND WEIGHT (UNITS) - 63. THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A CATHETER RESTRICTION ALARM. A BREAK OCCURRED IN THE BALLOON CATHETER AND BLOOD GOT INTO THE HELIUM LINE. BALLOON WAS TAKEN OUT WITHOUT PATIENT HARM. THERE WAS NO REPORTED INJURY TO THE PATIENT. MEDWATCH (B)(4) RECEIVED 30-APRIL-2020: INTRA-AORTIC BALLOON PUMP(IABP) DEVICE WITH AXILLARY VASCULAR ACCESS ALARM SOUNDED. RN WENT TO ROOM TO CHECK PATIENT AND DEVICE, FOUND HELIUM LINE WITH APPEARANCE OF BLOOD/RED FLUID. AMOUNT OF BLOOD IN HELIUM GAS LINE APPEARED TO INCREASE. PATIENT VITAL SIGNS STABLE. PUMP TURNED OFF AND TUBING CLAMPED. PATIENT TRANSPORTED WITH EVERYTHING ATTACHED TO CATHETER LAB. IABP LINE REMOVED AND REPLACED. DEVICE INSPECTED BY PHYSICIAN, COULD NOT DETERMINE OR LOCATE LEAKAGE. DEVICE AT ISSUE SENT BACK TO MANUFACTURER FOR EVALUATION. DATE OF EVENT - (B)(6) 2020.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A CATHETER RESTRICTION ALARM. A BREAK OCCURRED IN THE BALLOON CATHETER AND BLOOD GOT INTO THE HELIUM LINE. BALLOON WAS TAKEN OUT WITHOUT PATIENT HARM. THERE WAS NO REPORTED INJURY TO THE PATIENT. MEDWATCH (B)(4) RECEIVED 30-APRIL-2020: INTRA-AORTIC BALLOON PUMP(IABP) DEVICE WITH AXILLARY VASCULAR ACCESS ALARM SOUNDED. REGISTERED NURSE (RN) WENT TO ROOM TO CHECK PATIENT AND DEVICE, FOUND HELIUM LINE WITH APPEARANCE OF BLOOD/RED FLUID. AMOUNT OF BLOOD IN HELIUM GAS LINE APPEARED TO INCREASE. PATIENT VITAL SIGNS STABLE. PUMP TURNED OFF AND TUBING CLAMPED. PATIENT TRANSPORTED WITH EVERYTHING ATTACHED TO CATHETER LAB. IABP LINE REMOVED AND REPLACED. DEVICE INSPECTED BY PHYSICIAN, COULD NOT DETERMINE OR LOCATE LEAKAGE. DEVICE AT ISSUE SENT BACK TO MANUFACTURER FOR EVALUATION. DATE OF EVENT - (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A CATHETER RESTRICTION ALARM. A BREAK OCCURRED IN THE BALLOON CATHETER AND BLOOD GOT INTO THE HELIUM LINE. BALLOON WAS TAKEN OUT WITHOUT PATIENT HARM. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414219 SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000108241

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR