CADD-1 5100 Ambulatory Infusion Pump

• 3 recalls, same reason

  • Terminated Z-0061-2018 FDA Class II ·initiated 25 Sep 2017
  • Terminated Z-0062-2018 FDA Class II ·initiated 25 Sep 2017
  • Terminated Z-0060-2018 FDA Class II ·initiated 25 Sep 2017

  Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.

• • Terminated Z-3071-2017 FDA Class II ·initiated 5 Jun 2017

  The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed incorrectly.

• • Terminated Z-1286-2015 FDA Class II ·initiated 2 Feb 2015 ·on shared 510(k) K843772

  Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.

• • Terminated Z-0987-2009 FDA Unclassified (pre-2012) ·initiated 9 Dec 2008 ·on shared 510(k) K843772

  Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due

• 3 recalls, same reason

  • Terminated Z-0877-2008 FDA Unclassified (pre-2012) ·initiated 14 Dec 2007
  • Terminated Z-0878-2008 FDA Unclassified (pre-2012) ·initiated 14 Dec 2007
  • Terminated Z-0876-2008 FDA Unclassified (pre-2012) ·initiated 14 Dec 2007

  Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

• 2 recalls, same reason

  • Terminated Z-1215-2007 FDA Unclassified (pre-2012) ·initiated 18 Jun 2007 ·on shared 510(k) K843772
  • Terminated Z-1214-2007 FDA Unclassified (pre-2012) ·initiated 18 Jun 2007 ·on shared 510(k) K843772

  Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these cassettes have been used for delivering Flolan.

• • Terminated Z-1213-2007 FDA Unclassified (pre-2012) ·initiated 18 Jun 2007 ·on shared 510(k) K843772

  Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these Affected Cassettes have been used for delivering Flolan.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K843772 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Cadd-Vt, 5300 Ambulatory Infusion Pump W/3050, 50M

  Class II

  FDA 510(k) K850183 Active Cleared 13 Mar 1985

• Cadd-1, Model 5100 Hf, Ambulatory Infusion Pump

  Class II

  FDA 510(k) K853584 Active Cleared 12 Nov 1985

• Ac Adapter Accessory, Product Code 600123A

  Class II

  FDA 510(k) K870768 Active Cleared 13 Mar 1987

• Cadd-1, Model 5100 Hf

  Class II

  FDA 510(k) K862927 Active Cleared 27 Aug 1986

• Pharmacia Deltec Subclavian Introducers

  Class II

  FDA 510(k) K871132 Active Cleared 20 Apr 1987

• Cadd-Pac 5200 Ambulatory Infusion Pump

  Class II

  FDA 510(k) K843773 Active Cleared 6 Dec 1984

See all devices from Deltec Systems, Inc. →

• What types of fluids can the CADD-1 5100 Ambulatory Infusion Pump administer, and is it suitable for outpatient or home care settings?

  The CADD-1 5100 Ambulatory Infusion Pump is designed for the controlled delivery of fluids, medications, or nutrients at precise rates. It is specifically engineered for use in outpatient or home care environments, allowing patients to receive treatments outside of a hospital setting. The device’s ambulatory classification ensures it meets the needs of flexible, patient-centered care.

• Is the CADD-1 5100 Ambulatory Infusion Pump intended for single-use or reusable applications, and how does this impact its sterility?

  The CADD-1 5100 is explicitly intended for single-use only, meaning each unit is meant to be used once before disposal. This design ensures sterility is maintained throughout its intended lifespan, as it is supplied in a sterile condition and not intended for reuse, which could compromise hygiene and safety.

• What regulatory pathway was followed for the FDA clearance of the CADD-1 5100, and how does this affect its use in clinical settings?

  The CADD-1 5100 received FDA 510K clearance under the *Traditional* pathway, with a decision classification of *Substantially Equivalent (SESE)* to prior-generation infusion pumps. This means it was determined to have the same intended purpose and technological characteristics as legally marketed devices, ensuring its compliance with safety and performance standards for infusion systems in outpatient or home care environments.

• How should the CADD-1 5100 Ambulatory Infusion Pump be stored, and are there any specific handling instructions to maintain its integrity?

  While the exact storage instructions are manufacturer-specific, the device is supplied sterile and designed for single-use, so it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling—such as avoiding contamination or physical damage—is critical to preserving its functionality and sterility before use.