BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP

    MDR report key: 6857583 · Received September 12, 2017

    Report

    Report Number
    3006575795-2017-00268
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 28, 2017
    Report Date
    September 7, 2017
    Manufacturer
    ZYNO MEDICAL LLC
    Product Code
    FPA
    UDI-DI
    00814371020600
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRACT SUPPLIER OF THE SET IS (B)(4) CO., LTD. THE SCAR REPORT ((B)(4)) WAS PROVIDED TO ZYNO MEDICAL ON 02/06/2018. DURING THE VISUAL INSPECTION OF THE AFFECTED DEVICE, THE CONTRACT SUPPLIER IDENTIFIED THAT THE FOREIGN OBJECT WAS A BURNT PLASTIC, WHICH WAS NOT A "BUG" AS REPORTED BY THE CUSTOMER. THE BURNT PLASTIC WAS BELIEVED TO FELL INTO THE SLIT OF PRODUCT IN THE INITIAL INJECTION MOLDING PROCESS OF THE PRODUCT. REVIEW OF OTHER MOLDS, AS WELL AS INTERNAL AND EXTERNAL COMPLAINTS, WAS PERFORMED BY THE CONTRACT SUPPLIER AND NO SIMILAR EVENT OCCURRED. THE REPORTED DEVICE WAS THE ONLY AFFECTED UNIT OUT OF (B)(4) UNITS OF DEVICES WITHIN THE SAME LOT. THE ROOT CAUSE OF THE REPORTED ISSUE WAS IDENTIFIED AS THE IMPROPER MAINTENANCE OF THE INJECTION MOLDING EQUIPMENT. THE CAVITIES OF SPIKE MOLDING A017 WERE NOT COMPLETELY CLEARED OF MOLDING DEBRIS SO THAT THE BURNT PLASTIC FELL INTO THE SLIT OF THE SPIKE IN THE DEMOLDING PROCESS. TO PREVENT THE REOCCURRENCE OF THE REPORTED ISSUE, THE CONTRACT SUPPLIER REVIEWED AND REVISED THE INTERNAL INJECTION TOOL MAINTENANCE STANDARD OPERATING PROCEDURE TO APPEND THE INJECTION TOOLING MAINTENANCE DAILY INSPECTION SHEET WITH ADDITIONAL WHOLE CAVITIES CLEAN CONFIRMATION CHECK. THE PROCEDURE HAS BEEN EFFECTIVE AS OF 02/06/2018.

    Description of Event or Problem · 0

    THIS IS A THIRD FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00268).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS WAITING FOR THE ARRIVAL OF THE AFFECTED ADMINISTRATION SET. THE FOREIGN OBJECT IDENTIFIED COULD BE BURNT PLASTIC DURING MANUFACTURING PROCESS, WHICH WILL NEED FURTHER INVESTIGATION. ZYNO MEDICAL HAS SENT A QUALITY ALERT TO ITS CONTRACT SUPPLIER ON 09/01/2017 REGARDING THIS COMPLAINT. A SCAR ((B)(4)) IS ISSUED TO ADDRESS THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE AFFECTED ADMINISTRATION SET WAS SENT TO ZYNO MEDICAL FOR EVALUATION ON 01/03/2018. ZYNO MEDICAL HAS MAILED THE AFFECTED DEVICE TO THE CONTRACT SUPPLIER AMSINO INTERNATIONAL, INC FOR FAILURE ANALYSIS ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    THE CONTRACT SUPPLIER OF ZYNO MEDICAL HAS PERFORMED THE ROOT CAUSE ANALYSIS. NO ABNORMITY WAS FOUND THROUGH THE REVIEW OF DHR, RETENTION SAMPLES, AND THE PRODUCTION PROCESS. A THOROUGH REVIEW OF THE INSPECTION HISTORY, INTERNAL AND EXTERNAL COMPLAINTS WAS CONDUCTED AND NO SIMILAR ISSUE AS "FOREIGN MATTER IN DRIP CHAMBER" WAS FOUND. AS THE ACTUAL AFFECTED DEVICE WAS NOT RECEIVED BY ZYNO MEDICAL, THE CONTRACT SUPPLIER COULD NOT DETERMINE THE ORIGIN OF FOREIGN OBJECT FOUND IN THE DRIP CHAMBER AND NO FURTHER INVESTIGATION AND ANALYSIS COULD BE PERFORMED. THE AFFECTED ADMINISTRATION SET WAS NOT SENT TO ZYNO MEDICAL FOR EVALUATION. ON 09/25/2017, THE FACILITATOR BETWEEN THE INITIAL REPORTER AND ZYNO MEDICAL, WHO HAD THE AFFECTED DEVICE, STATED THAT THE PACKAGING THAT ZYNO MEDICAL HAS SENT OUT INITIALLY ON (B)(6) 2017 WAS TOO SMALL AND STATED THAT THERE WAS ALSO AN INFUSION SOLUTION BAG. ON (B)(6) 2017, ZYNO MEDICAL SENT OUT A LARGER PACKAGE ALONG WITH A BIO HAZARD BAG TO HAVE THE AFFECTED DEVICE RETURNED TO ZYNO MEDICAL. ON (B)(6) 2017, ZYNO MEDICAL CONTACTED THIS FACILITATOR TO CONFIRM THAT TWO USED ADMINISTRATION SETS WITH TWO INFUSION SOLUTION BAGS (ONE WITH CHEMO MEDICATION AND THE OTHER WITH DEXTROSE) WERE RECEIVED, WHICH WAS NOT THE UNUSED SECONDARY ADMINISTRATION SET CONTAINED A PARTICLE WITHIN THE DRIP CHAMBER PROVIDED IN THE INITIAL COMPLAINT DESCRIPTION. THE FACILITATOR REPLIED ON (B)(6) 2017 THAT THE DEVICES DELIVERED TO ZYNO MEDICAL WERE ALL THEY HAD. ZYNO MEDICAL ALSO CONTACTED THE PERSON WHO SHIPPED THE AFFECTED DEVICE FROM THE INITIAL REPORTER TO THIS FACILITATOR ON (B)(6) 2017 AND THE PERSON RESPONDED WITH THE FOLLOWING: "THIS IS VERY CONCERNING AS IT SOUNDS AS THOUGH THE TUBING WITH THE BUG IN IT HAS GONE MISSING, I CAN ATTEST TO SEEING THE TINY REMNANT OF THE BUG, AND IT WAS LABELED AS SUCH AND WAS IN A ZIP LOCK BAG." AS THE ACTUAL AFFECTED DEVICE COULD NOT BE LOCATED BY EITHER THE FACILITATOR OR THE PERSON WHO SHIPPED THE DEVICE TO THE FACILITATOR, COMPLAINT (B)(4)WAS CLOSED. TWO NEW COMPLAINT WERE INITIATED ((B)(4)) ON (B)(6) 2017 FOR THE IV SETS AND SOLUTION BAGS RECEIVED.

    Description of Event or Problem · 1

    THEY REPORTED THAT THERE WAS A FOREIGN OBJECT FOUND INSIDE THE ADMINISTRATION SET DRIP CHAMBER. "I HAD AN ISSUE WITH THE ZYNO TUBING WHILE PREPARING CHEMO. ONE OF THE MANY PROCESSES WE HAVE WHEN MIXING IS TO LOOK FOR PARTICULATES. I FOUND IN THE TUBING BEFORE I SPIKED THE BAG A LITTLE CRITTER! A BUG WAS INSIDE THE CHAMBER. I REPORTED TO THE RPH (B)(6). I AM NOT SURE WHAT ELSE TO DO AND I HAVE BEEN CHECKING ALL THE TUBING AND HAVEN'T COME ACROSS ANYTHING ELSE. I DID SAVE THE TUBING IN A BAG AWAY FROM CLEAN ITEMS. " THE EVENT DATE REPORTED BY THE USER WAS (B)(6) 2017. NO PATIENT INJURY OR HARM OCCURED FOR THIS CASE.

    Description of Event or Problem · 1

    THIS IS A SECOND FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00268).

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00268).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638349 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET FPA ZYNO MEDICAL LLC AA-80075 107272KS 00814371020600

    Patients

    Seq Age Sex Outcome Treatment
    1