Description of Event or Problem · 1
A FEMALE PT HAD A PERIPHERALLY-INSERTED CENTRAL VENOUS CATHETER INSERTED IN INTERVENTIONAL RADIOLOGY WITHOUT PROBLEMS. THE EVENT WAS CHARACTERIZED BY CYANOSIS, GASPING, UNRESPONSIVENESS -APPROX 5 MINUTES-, AND A GRAND MAL SEIZURE AND OCCURRED AFTER THE NEW PICC WAS FLUSHED WITH HEPARIN -HOSPIRA 100 UNITS/ML 10 ML VIAL-. NO HYPOTENSION WAS DOCUMENTED. THE NURSE REPORTS THAT THE HOSPIRA 100 UNITS/ML 10 ML VIAL -LOT 56-463--DK- WAS USED IN THIS CASE AND THAT THE REACTION WAS SIMILAR TO TWO CASES PREVIOUSLY REPORTED. THIS BRAND AND LOT OF HEPARIN WAS REPORTED TO THE MFR AND FDA IN RESPONSE TO THE TWO PREVIOUS CASES AND HAS NOT BEEN REPORTED TO BE CONTAMINATED. TIMELINE: 1300: PATIENT VERBALIZES SHE DOESN'T FEEL WELL AND STATES SHE IS "SEEING STARS" WITHIN A MINUTE AFTER HEPLOCK INJECTION. PATIENT HAD A SEIZURE EPISODE LASTING ABOUT 30 SEC. PATIENT'S FACE TURNED PURPLE AND SHE HAD GENERALIZED CLONIC CONTRACTIONS AND DID NOT RESPOND TO VERBAL QUESTIONS. 1305: PATIENT WAS NOW AWAKE AND CRYING. BP 148/106, HR 120, SAO2 76-88% ON ROOM AIR. O2 STARTED 1310: PATIENT MORE COHERENT NOW. BP 130/55; HR 108, SAO2 97% ON ROOM AIR. 1315: PATIENT STABLE, TRANSFERRED BACK TO FLOOR, BP 130/76, HR 104, SAO2 94% ON ROOM AIR. DOSE OR AMOUNT: UNKNOWN VOLUME TO FLUSH, FREQUENCY: ONCE, ROUTE: IV. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: FLUSH PICC LINE.