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

Model Number 2202-0007

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: 150ml baxter bag container lot dr18k12045.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.

Event Description

It was reported that upon entering the infant's room to hang platelets, the nurse discovered a small white puddle on the floor that was determined to be 20% intralipids.The rate of infusion was 4ml/hr to infuse over 20 hours using a 1.2 micron filter.Upon further investigation, the nurse noticed that the lipids where slowly dripping down the pump module.When the nurse opened the channel door a tear in the iv tubing was found to be leaking the lipids.There was "emotional distress or inconvenience" for the patient.

Manufacturer Narrative

The customer¿s report that the tubing leaked and had a tear in the iv tubing was not confirmed.Inspection under magnification of the set's components and infusion bag observed no obvious damages or issues.An attempted reprime, infusion ran at the reported rate, and pressure tested of the received set noted no leaks or any issues.Further testing was performed.A lab gauge needle was manually attached to the male luer end of the reprimed set and the set was loaded into a lab pump module.An infusion was programmed to run at the reported rate of 4ml for one hour.The infusion completed as expected with no leaks, alarms, or any issues observed.The set was also pressure tested while submerged underwater.Each of the set's tubing engagements were manipulated as well as the silicone segment component being slightly stretched while the pressure was gradually increased up to 30psi.No leaks or any issues were observed.The root cause was not identified.

Event Description

It was reported that upon entering the infant's room to hang platelets, the nurse discovered a small white puddle on the floor that was determined to be 20% intralipids.The rate of infusion was 4ml/hr to infuse over 20 hours using a 1.2 micron filter.Upon further investigation, the nurse noticed that the lipids where slowly dripping down the pump module.When the nurse opened the channel door a tear in the iv tubing was found to be leaking the lipids.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8562642
• MDR Text Key: 143991936
• Report Number: 9616066-2019-01100
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403274039
• UDI-Public: 10885403274039
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2202-0007
• Device Catalogue Number: 2202-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THERAPY DATE: (B)(6) 2019
• Patient Age: 18 MO