MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10062818

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2015

Event Type  malfunction  

Event Description

Customer reported administration of platelets was prolonged when an unknown volume of normal saline infused rather than the platelets even though the normal saline tubing was clamped.A hemostat was used to clamp the normal saline tubing so that the platelets could infuse.No patient harm reported.

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Manufacturer Narrative

The customer¿s report that the administration of platelets was prolonged when an unknown volume of normal saline infused rather than the platelets even though the normal saline tubing was clamped was not confirmed.During the visual inspection the blood set was inspected for kinks, incomplete bonding engagements, and holes/tears in the tubing or damages to other components.Other than kinks in the tubing that were caused from the slide clamps and shipping no anomalies were observed.Functional testing was performed and the infusion was started on the primary bag and completed successfully without any fluids from the primary bag flowing into the secondary bag.Pressure testing was performed and there were no signs of leaking.The root was not identified.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 4869491
• MDR Text Key: 17536238
• Report Number: 9616066-2015-00825
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10062818
• Device Catalogue Number: 10062818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1