The Alaris PC Unit, Model 8015 (manufactured or serviced… recallZ-1792-2009 · Cardinal Health 303 dba Cardinal Health · initiated Jun 12, 2009

Why it was recalled

There is a potential in the specified ESD (electrostatic discharge) protection circuitry in the keypad of Alaris PC units manufactured or serviced between April 2008 through January 2009. In these units there is a potential for the keypad not being responsive, key entries without key presses, or key entries that register incorrectly which may result in an over-infusion or under-infusion. An over

FDA root cause category: Device Design

What the company is doing

The recall was initiated on June 12, 2009 with the firm forwarding via UPS an Urgent: Medical Device Recall Notification with attached Customer Response Card to the Chief Administrative Officer, Director of Pharmacy, Director of Biomedical Engineering, Director of Nursing & Director of Risk Management of all of the affected consignees. Customers were also asked to please promptly complete and return the enclosed Customer Response Card to expedite the correction process. The Recall Notification informed the consignees of: (A) PROBLEM #1: Occlusion Warning Message for Alaris Pump Module; (B) PROBLEM #2 Syringe volume Warning Message for Alaris PCA module; (C) PROBLEM #3 Electrostatic Discharge (ESD) protection circuitry; (D) PROBLEM #4 Fluid Ingress and (E) PROBLEM #5 Alaris System Inter-Unit Interface (IUI) Connectors Labeling. The recall notice included "Required Action for Users & Follow-up actions by Cardinal Health for all five problems. Customers were also asked to report any adverse reactions experienced with the use of this product, and/or quality problems to the FDA's MedWatch Program. In addition, customer were provided the following contact information for the recall: (1) Cardinal Health Recall Center for general questions: By phone at 1-888-562-6018 7am to 5pm (Pacific) ; (2) Customer Advocacy for adverse reports: By phone at 1-800-854-7120, Option 1, Option 1, Option 3 or by email at [email protected] 24 hours a day, Sunday-Saturday; (3) Technical Support for Technical Questions regarding the Alaris System: By phone at 1-888-562-6018, 6am-5pm (Pacific). The firm followed-up with the release of a nationwide press statement regarding this issue on July 29, 2009. The press release indicated serial numbers of affected devices, as well as CareFusions short term instructions to customers, and the firms strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/ (This informatio

Recall details

Recall number

Z-1792-2009

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Jun 12, 2009

Posted by the FDA

Aug 3, 2009

Recalling firm

Cardinal Health 303 dba Cardinal Health

Quantity

30,000 units

Product code

FRN

FDA submissions

K051641

Distribution

Worldwide Distribution -- US (including Puerto Rico and Guam), Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand.

Product description

The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January 2009). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules.

Other devices under the same FDA submission

1 device cleared under K051641 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Alaris 8015

  Carefusion 303, Inc. · Pump, infusion
  2 recalls45 deaths148,093 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 52119).

• Z-1790-2009 · Terminated
  The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above.
• Z-1791-2009 · Terminated
  The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). The Alaris PC Unit is the…
• Z-1793-2009 · Terminated
  Alaris Pump Module, Model 8100.
• Z-1794-2009 · Terminated
  Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patien…