Description of Event or Problem · 0
WHAT HAPPENED: ON [REDACTED], [REDACTED] HOSPITAL WAS NOTIFIED BY THE [REDACTED] DEPARTMENT OF PUBLIC HEALTH OF CONTAMINATED IV TUBING SETS FROM THE MANUFACTURER, ICU MEDICAL. PER THE ALERT RECEIVED, "THE [REDACTED] DEPARTMENT OF PUBLIC HEALTH HAS BEEN MADE AWARE OF REPORTS IN OTHER STATES OF CONTAMINATED IV TUBING SETS FROM A SINGLE MANUFACTURER WITH NATIONAL DISTRIBUTION AND IS ALERTING [REDACTED] HEALTH CARE FACILITIES TO INSPECT THEIR SUPPLIES. THE CONTAMINATION IS REPORTED AS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS AND HAS BEEN REPORTED IN NUMEROUS LOTS ACROSS THREE PRODUCT TYPES FROM ICU MEDICAL. IN SOME PRODUCTS, PARTICULATE MATTER APPEARS IN THE LUMEN OR CHAMBER OF THE TUBING. IN MOST, PARTICULATE MATTER APPEARS EMBEDDED IN THE PLASTIC MATERIAL BUT NOT WITHIN THE LUMEN OR CHAMBER. PRELIMINARY REPORTS OF SIMILAR FINDINGS IN A SECOND STATE SUGGEST THIS MAY BE A WIDESPREAD ISSUE WITH ONE OR MORE NATIONALLY DISTRIBUTED PRODUCT LINES. THE PRESENCE OF FOREIGN MATERIAL IN INFUSION MATERIALS MAY POSE A HEALTH RISK TO PATIENTS. IT IS UNKNOWN WHETHER THE PARTICULATES CONTAIN BIOLOGICAL MATERIAL. NO INFORMATION IS AVAILABLE AT THIS TIME ABOUT THE DATES WHEN THESE LOTS WERE SHIPPED TO [REDACTED] OR USED. NO ADVERSE EVENTS HAVE BEEN LINKED TO THE CONTAMINATED PRODUCTS. THE MANUFACTURER, THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) HAVE BEEN NOTIFIED AND ARE INVESTIGATING." WHO IS AFFECTED: AT [REDACTED], A PRIMARY TUBING SET WAS IDENTIFIED WITH THE BLACK SPECKS. OTHER SECONDARY TUBINGS INCLUDED IN THE IDENTIFIED LOT NUMBERS ARE NOT KNOWN TO BE IMPACTED. WHAT IS BEING DONE: AT [REDACTED], INSTRUCTIONS ARE PROVIDED FOR CONTINUED ENHANCED VISUAL INSPECTION BY MATERIALS MANAGEMENT AND THE FRONTLINE TEAM OF ALL THE IV TUBING SETS PRIOR TO USE. PRODUCT: ENHANCED MONITORING FOR IMPACTED PRODUCTS AT [REDACTED]. CLINICAL GUIDANCE: ENHANCED VISUAL INSPECTION OF ICU MEDICAL SECONDARY TUBING PRIOR TO USE EVENT FOR NON-IMPACTED LOTS; ANY CONCERNS SHOULD BE ESCALATED AND PRODUCT REMOVED FROM SERVICE. TARGETED COMMUNICATIONS: A CONCISE ONE-PAGER IS BEING FINALIZED FOR FRONTLINE STAFF AT POTENTIALLY IMPACTED SITES [REDACTED]. A WEB VERSION IS BEING CREATED TO SUPPORT VERSION CONTROL. [REDACTED] CONTINGENCY PLANNING: INBOUND INVENTORY IS BEING INSPECTED AHEAD OF THE SCHEDULED ICU MEDICAL PUMP GO-LIVE WITH CONTINGENCY PLANNING IN PLACE SHOULD RISK OR SCOPE CHANGE. [REDACTED] CONTINGENCY PLANNING: INBOUND INVENTORY IS BEING INSPECTED AHEAD OF THE SCHEDULED ICU MEDICAL PUMP GO-LIVE WITH CONTINGENCY PLANNING IN PLACE SHOULD RISK OR SCOPE CHANGE. CONTINUE COORDINATION WITH ICU MEDICAL AND MEDLINE AS TESTING RESULTS BECOME AVAILABLE.