Description of Event or Problem · 1
PATIENT RECEIVES ADVATE VIA HIS "IMPLANTOFIX" TWICE WEEKLY AND AS NEEDED FOR BLEEDING EPISODES. HEPARIN IS INSTILLED IN THE LINE FOLLOWING HIS INJECTIONS FOR LINE PATENCY. MEDEFIL HAS VOLUNTARILY RECALLED SOME LOTS OF THE HEPARIN PRODUCT THAT WERE DISPENSED TO PT. IN OUR RECALL LETTER, WE ARE INFORMING FAMILIES THAT THERE HAVE BEEN REPORTS OF LOW BLOOD PRESSURE, SHORTNESS OF BREATH, NAUSEA, VOMITING OR ABDOMINAL PAIN WITH HEPARIN PRODUCTS, HOWEVER, NO REPORTS WITH THE MEDEFIL BRAND PRODUCT. UPON INFORMING PT'S MOTHER, SHE STATED THAT THE PT COMPLAINED OF STOMACH PAIN TWO DAY IN 2008. HE REC'D ADVATE FOLLOWED BY HEPARIN THREE DAYS EARLIER. PER MOTHER, NO OTHER FAMILY MEMBERS HAVE HAD GI UPSET. MOTHER STATES, THAT SHE WILL CONTACT PHYSICIAN. DOSE OR AMOUNT: 3 ML, FREQUENCY: ONCE DAILY, ROUTE: IV. DATES OF USE: NINE DAYS IN 2008. DIAGNOSIS OR REASON FOR USE: CATHETER PATENCY.