CADD-Prizm PCS II Model 6101 Ambulatory Infusion System

• • Terminated Z-0718-2007 FDA Unclassified (pre-2012) ·initiated 19 Jan 2007

  The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.

• • Terminated Z-0980-03 FDA Unclassified (pre-2012) ·initiated 23 Jun 2003

  Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.

510(k) Number

K000842 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Port-A-Cath P.A.S. Port II Implantable Venous Access Sytems

  Class II

  FDA 510(k) K961580 Active Cleared 20 Sep 1996

• Sims Silo Needle De-Access Enclosure

  Class II

  FDA 510(k) K935767 Active Cleared 15 Nov 1995

• Port-A-Cath II Trans-Arterial Percutaneous System

  Class II

  FDA 510(k) K992697 Active Cleared 18 Nov 1999

• Cadd Administration Set, Cadd 250ml Flexible Medication Reservoir, Modified Securit Shell, Security Shell Adapter

  Class II

  FDA 510(k) K990083 Active Cleared 12 Feb 1999

• Port-A-Cath Low-Profile Implantable Access Systems

  Class II

  FDA 510(k) K973862 Active Cleared 29 Dec 1997

• Cadd Administration Set

  Class II

  FDA 510(k) K991599 Active Cleared 15 Jun 1999

See all devices from Sims Deltec, Inc. →

• What types of infusions can the CADD-Prizm PCS II Model 6101 deliver, and how is it programmed for use?

  The CADD-Prizm PCS II Model 6101 is designed to deliver intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, or subarachnoid infusions. It supports both continuous-rate infusions and patient-controlled demand dosing, including applications like patient-controlled analgesia (PCA). Programming is required for constant-rate or bolus-dose delivery, making it versatile for outpatient or home infusion therapy in general hospital settings.

• Is the CADD-Prizm PCS II Model 6101 intended for single-use or reusable applications, and what does this mean for sterility?

  The CADD-Prizm PCS II Model 6101 is explicitly labeled as a single-use device, which means it is not meant to be reused after one patient use. Since it is non-sterile, it must be handled in a manner that maintains aseptic conditions during setup and infusion to prevent contamination, particularly in clinical environments like hospitals or outpatient care.

• What regulatory pathway was followed for FDA clearance of the CADD-Prizm PCS II Model 6101, and what does this imply for its use?

  The CADD-Prizm PCS II Model 6101 received FDA clearance through a 510(k) pathway, specifically under regulation 880.5725 for infusion pumps, with a decision code of SESE (Substantially Equivalent). This implies the device was determined to be comparable to a legally marketed predicate device, allowing it to enter the market without requiring a full premarket approval process. It is classified under the Pump, Infusion category and is intended for use in general hospital settings, including outpatient or home infusion therapy.

• Does the CADD-Prizm PCS II Model 6101 have any safety considerations related to MRI environments?

  The device documentation does not specify any MRI safety information, meaning there is no confirmed compatibility or safety data regarding its use in magnetic resonance imaging environments. Clinicians should assume the device is not MRI-safe unless explicitly stated otherwise, and avoid exposing it to MRI fields to prevent potential malfunctions or hazards.