MAUDE Adverse Event Report: HOSPIRA, INC. PLUM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1425328

Device Problems Leak/Splash (1354); Reflux within Device (1522); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2019

Event Type  malfunction  

Event Description

While responding to an infusion pump alarm the rn noticed blood backing up in uv line tubing, causing alarm to beep off showing occlusion.Staff then noticed that in-line filter was leaking fluids through the air vent ports.Rn's determined that the infusion set required complete sterile tubing change of all tubing and flushing "off" uv line to clear blood from line.Tubing exchanged and sent to biomedical for reporting and evaluation.The nicu unit has had continuing failures of the infusion inline sets and this particular infusion set was noted on a set with a downstream filter (the filter "place" distally to the infusion set pumping cassette).Manufacturer response for primary infusion set, 2 clave y-site with 0.2 micron filter, primary plum set (per site reporter).This is an on-going issue with the iv set and pump manufacturer on leaking 0.2 micron in-line filters.These have been reported in previous medwatch submissions.The manufacturer is currently investigating the cause for the filter leaks and has attempted to provide our medical center with alternate lot numbers of the infusion sets.We have continued to have filter leakage issues on the different lot numbers as well as different infusion sets with the filters located both proximally and distally to the pump cassette.We have increased our monitoring vigilance and reporting of any "line" that "have" fluid leakage from the 0.2 micron filter.

• Brand Name: PLUM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 8247870
• MDR Text Key: 133075446
• Report Number: 8247870
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1425328
• Device Catalogue Number: 1425328
• Device Lot Number: 925795H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA