FDA Adverse Event Injury Summary report: N

ABBOTT

MDR report key: 496476 · Received November 12, 2003

Report

Report Number: MW1030224
Event Type: Injury
Date Received: November 12, 2003
Date of Event: April 8, 2003
Report Date: November 12, 2003
Manufacturer: ABBOTT
Product Code: FMF
Adverse Event: Yes
Report Source: Voluntary report
Reporter Location: CO, US
Reporter Occupation: PHARMACIST

Narratives

Description of Event or Problem · 1

UNDER FLUOROSCOPIC GUIDANCE, A DOUBLE-LUMEN POLYURETHANE BARD PERIPHERALLY-INSERTED CENTRAL CATHETER WAS PASSED INTO THE DISTAL SUPERIOR VENA CAVA AND THEN SECURED. THE CATHETER WAS FLUSHED WITH HEPARINIZED SALINE. THE PT BECAME ERYTHEMATOUS WITH SOME FACIAL SWELLING AND DIFFICULTY BREATHING. THEY BECAME HYPOTENSIVE WITH A SYSTOLIC BLOOD PRESSURE OF 90 MM HG. PT WAS TREATED IMMEDIATELY WITH IV FLUIDS, OXYGEN BY NON-REBREATHER MASK, AND DIPHENHYDRAMINE 50 MG INTRAVENOUSLY. MOST SYMPTOMS SUBSIDED, BUT PT THEN COMPLAINED OF ABDOMINAL PAIN AND NAUSEA. FENTANYL 50 MCG AND ONDANSETRON 4 MG WERE ADMINISTERED INTRAVENOUSLY, WITH PROMPT SYMPTOMATIC RESOLUTION. THE PICC LINE WAS LEFT IN PLACE AND WAS USED WITHOUT FURTHER PROBLEM. APPROXIMATELY 3 WEEKS LATER, THIS PT REQUIRED REPLACEMENT OF THE CENTRAL IV LINE BECAUSE OF DISPLACEMENT. A SILICONE GROSHONG CATHETER WAS PLACED AND CONFIRMED WITH FLUOROSCOPY TO BE IN POSITION AT THE RIGHT ATRIAL-SUPERIOR VENA CAVA JUNCTION. AFTER INSERTION THE CATHETER WAS FLUSHED WITH NORMAL SALINE. THE PT SUBSEQUENTLY EXPERIENCED AN ANAPHYLACTOID REACTION SIMILAR TO THE EVENT DESCRIBED ABOVE. PT WAS TREATED SIMILARLY WITH PROMPT SYMPTOMATIC RESOLUTION. THE CATHETER WAS LEFT IN PLACE AND USED WITHOUT FURTHER PROBLEM OR COMPLICATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ABBOTT	SODIUM CHLORIDE	FMF	ABBOTT	*	*
2	BARD	PICC	DQO	BARD	*	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR		Hospitalization