[Perfusion instruments: analysis of product surveillance in 1998 and its on-the-job training. Subcommittee 4b for Product Surveillance]. / Matériels de perfusion: le bilan de la matériovigilance en 1998 et ses enseignements pour la pratique. Sous-commission 4b de matériovigilance.

OBJECTIVES: To analyze retrospectively the data base of the French national vigilance reporting system concerning infusion devices during the year 1998. METHODS: Each report has been reviewed and classified, except implantable catheter ports. RESULTS: The study included 309 reports. Among them, 28% concerned infusion pumps and 72% single use devices, i.e. catheters, infusion lines, taps, connectors, etc. We observed six deaths and 23 severe incidents. Only 25% of devices could be formally investigated by manufacturers. The origins of incidents were very different between infusion pumps and single use devices. The first showed simple failures, software errors, maintenance omissions or errors, and problems related to obsolescence of the device. The second revealed manufacturer quality insurance failures, design and utilization errors, and problems related to the technique itself rather than device. DISCUSSION: Our findings are similar to the few data available in international literature. They address the need to obtain an adequacy between the performances of devices which vary with generations of devices and the clinical risks: newest and safest devices should be preferred for the infusion of the most critical drugs.

[Equipment surveillance of implantable catheter ports (1996-1998). Members of Sub-Commissions 4a and 4b for Equipment Surveillance]. / Matériovigilance des chambres à cathéter implantables en France (1996-1998). Les Membres des Sous-Commissions 4a et 4b de Matériovigilance.

We analyse all incident reports to the French Health Ministry over the 1996-1998 period, concerning implantable catheter ports. They represent 7% of all reports in the field of anaesthesia and intensive care. Two hundred eleven reports have been analysed. There were 93 catheter ruptures with 77 intravascular migrations. In more than 50% of cases, a pinch-off syndrome mechanism was responsible of these ruptures and a displacement of the O'ring was involved in 25%. Additional minor complications were reported and discussed in regard to literature. We conclude that implantable catheter ports may lead to serious incidents which are preventable in most cases.