OPTIVANTAGE WITH PEDESTAL

MDR report key: 2881514 · Received December 18, 2012

Report

Report Number: 1518293-2012-00225
Event Type: Injury
Date Received: December 18, 2012
Report Date: December 18, 2012
Manufacturer: LIEBEL-FLARSHEIM CO.
Product Code: DXT
PMA / PMN Number: K042744
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

CUSTOMER REPORTS A FEMALE PATIENT OF APPROXIMATELY 60 YEARS OF AGE EXPERIENCED RUPTURED VEINS DURING AN UNKNOWN PROCEDURE. CUSTOMER REPORTS SUSPICION OF EXCESSIVE PRESSURE IN THE SYSTEM. THE POSITIONING OF THE NEEDLE AT THE PATIENT WILL ALWAYS BE CHECKED ON THE PATIENT WITH OUR BOLUS PRIOR TO THE GENERAL EXAMINATION. EVERYTHING OK. THE ARM OF THE PATIENT WAS KEPT OUTSTRETCHED DURING INJECTION, NO BENDING OF THE VESSELS. THE MAIN INJECTION WAS CANCELED AFTER THE HALF OF THE TREATMENT. PRESSURE LIMIT WAS NOT REACHED, NO BREAK OFF PER DEVICE ALARM BUT BY THE STAFF. IV ACCESS SITE: IV-ACCESS ABOVE THE RIGHT OR LEFT CROOK OF THE ARM. IV ACCESS DEVICE: VASOFIX SAFETY 20G X 1 1/4", BRAUN. NEEDLELESS DEVICE NOT USED. NO INJECTION PROTOCOL EXISTING. VOLUME OF CONTRAST INFILTRATED: CONTRAST MEDIA 100ML AND NACL 50ML. ADJUSTMENT: PRESSURE LIMITS 300PSI, FLOW RATES OF 3ML/S. THERE WAS NO NEGATIVE FEEDBACK OF THE PATIENT. PATIENT WAS TREATED WITH HEPARIN OINTMENT, COOLING, PRESSURE BANDAGE FOR A MINIMUM OF AN HOUR AND DISCHARGED BY PHYSICIAN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OPTIVANTAGE WITH PEDESTAL		DXT	LIEBEL-FLARSHEIM CO.	OPTIVANTAGE	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Other