---

Major Medical Device OEM Completes FCA On-Time and Under Budget with Quest International

---

Challenge

One of the leading manufacturers of neo-natal infusion pumps wanted to perform a voluntary Field Corrective Action (FCA) on its install base to replace a potentially defective mechanical assembly responsible for dosage control.

The OEM sought out a service partner that would be able to deploy a team of qualified and certified resources to perform the repair on the affected neo-natal pumps at its customers’ facilities. The partner would need to adhere to strict budgetary restrictions and complete the FCA at a fixed cost per device.

The selected partner would have to:

• Perform the FCA on 12,000 affected pumps at 180 consignee sites
• Achieve a completion rate of at least fifteen (15) pumps per day
• Maintain a failure rate of less than two (2) percent
• Complete the program in less than 5 months

---

Solution

Quest International analyzed the details supplied by the OEM and was able to carefully design and then implement a solution that would meet the OEM's budgetary and performance-related requirements.

Quest allocated a series of lead field technicians to receive the initial training and certification by the OEM, these lead technicians would deploy as tiger teams to each facility and build, train and certify a local team of technicians to rework/remediate affected pumps based on the hospital availability.

These teams maintained strict adherence to Quest’s quality management system, which is governed by our ISO registrations: ISO 9001:2015, ISO 13845: 2016, ISO 14001:2015, and ISO 27001:2022, resulting in exceptional work that exceeded the OEM’s requirements.

---

Results

The pumps were inspected and replaced as necessary. Quest utilized its QuestNetSM service management portal to keep the OEM apprised of scheduled dates at impacted customer locations until the project was completed.

All remediated pumps were inspected and had documentation completed to Good Documentation Practice (GDP) compliant standards. The reports were submitted back to the OEM’s quality and regulatory teams.

Quest’s tiger team model enabled the OEM to have the work performed on time and under budget for a successful FCA.