FDA Adverse Event Injury Summary report: N

HEPARIN LOCK FLUSH SOLUTION USP

MDR report key: 981909 · Received January 2, 2008

Report

Report Number
MW5005023
Event Type
Injury
Date Received
January 2, 2008
Date of Event
November 19, 2007
Report Date
January 2, 2008
Product Code
NZW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

MY MOTHER RECENTLY REC'D A PHONE CALL FROM INFUSION TECHNOLOGIES, INC. INFORMING HER THAT THE HEPARIN LOCK FLUSH SOLUTIONS USP -LOT #070926H-SYRINGES COULD BE CONTAMINATED AND THAT SHE SHOULD DISPOSE OF ANY MEDICATION THAT WAS LEFT. MY MOTHER UNDERSTOOD THE CALL TO MEAN THE CEFEPIME AS REPORTED BELOW THAT WAS BEING ADMINISTERED AND DID NOT UNDERSTAND THAT IT WAS THE SYRINGES. HERE IS A SEQUENCE OF WHAT I UNDERSTAND HAS HAPPENED: SOMETIME IN 2007, SHE WAS RECEIVING DAILY ADMINISTRATION OF CEFEPIME THROUGH A PICC LINE BY A HOME HEALTH AGENCY. THE REASON FOR THE ANTIBIOTIC WAS DUE TO A SEVERE INFECTION ON HER LEG. WE WERE VISITING HER AT THE TIME AND IMMEDIATELY AFTER SHE REC'D THIS MEDICATION, SHE BECAME VERY ILL AND RAN A VERY HIGH FEVER AND HAD CHILLS. EIGHT DAYS LATER, SHE WAS ADMITTED TO HOSP AND REMAINED THERE FOR APPROX ONE WEEK. SHE WAS VERY ILL WITH A HIGH FEVER, CHILLS, FREQUENT URINATION AND BROKE OUT IN A RASH OVER HER ENTIRE BODY. WE NEVER REC'D ANY WORD OF THE EXACT CAUSE OF HER ILLNESS, BUT UPON ENTERING THE HOSP, THEY REMOVED THE PICC LINE AND RAN LAB WORK ON THE LINE, AFTER WE REPORTED THE FACT THAT SHE WAS GETTING ILL IMMEDIATELY AFTER THE HOME HEALTH NURSE GAVE HER THE MEDICATION. SINCE THEN, I HAVE TALKED TO DR. THE WOUND CTR DR THAT TOLD US TO TAKE HER TO THE ER, AND HIS CHART REPORTS THAT THE PROBLEMS WERE DUE TO AN INFECTION FROM THE PICC LINE -- HE WAS NOT AWARE OF THE RECALL OF THE SYRINGES. SHE IS NOW BACK IN THE HOSP - ADMITTED FOLLOWING MONTH - AND HAS BLEEDING FROM HER RECTAL AREA -- THEY RAN A COLONOSCOPY THIS MORNING AND HER PRIMARY DR REPORTS THAT SHE HAS ISCHEMIC COLITIS. I TALKED TO DR THIS MORNING AND HE SAYS HE IS AWARE OF THE RECALL OF THE SYRINGES. I TALKED TO INFUSION TECHNOLOGIES THIS MORNING AND THEY FAXED ME A COPY OF DR, MD -CDC, GA- LETTER CONCERNING THE RECALL. MY CONCERN IS THIS: I AM RELATIVELY POSITIVE THAT THE WEEK-LONG HOSP STAY IN THE PREVIOUS MONTH WAS DUE TO THE CONTAMINATED HEPARIN FLUSH SYRINGES BECAUSE OF THE NATURE OF HER SYMPTOMS - FEVER, CHILLS, ETC. EVEN THOUGH SHE WAS RECEIVING AN ANTIBIOTIC AT THE TIME. NO ONE HAS EVER CONTACTED HER TO TELL HER THIS WAS THE CAUSE OF HER ILLNESS. ALSO, THIS IS MY PRIMARY CONCERN: WHAT ARE THE FAR-REACHING IMPLICATIONS OF THIS INFECTION -- IS THERE PERMANENT DAMAGE OR RECURRING DAMAGE DUE TO THIS CONTAMINATION? DOSE OR AMOUNT: 5 ML IN 12 ML SYRINGE. FREQUENCY: 1 X DAILY. DATES OF USE: APPROXIMATELY NINE DAYS IN 2007. DIAGNOSIS OR REASON FOR USE: LEG INFECTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HEPARIN LOCK FLUSH SOLUTION USP NONE NZW 070926H

Patients

Seq Age Sex Outcome Treatment
1 YR Hospitalization