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

Model Number 2432-0007

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Type  Injury  

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.

Event Description

The customer reported that they found 0.9% ns leaking at the filter of the tubing.The patient spiked a fever and the blood culture results were positive for infection.There was no report of lasting harm.

Manufacturer Narrative

The customer¿s report of leaking at the filter was confirmed.Visual inspection under magnification showed no holes/tears in the filter membrane or damage to the filter housing.Functional and pressure testing confirmed leaking from the filter vent closest to the output port.The root cause of the filter vent leak was identified as the fluid resistance of the filter becoming roughly equivalent to the fluid resistance of the air vent after becoming clogged from prolonged exposure.

• 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: 7404232
• MDR Text Key: 104606942
• Report Number: 9616066-2018-00398
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2432-0007
• Device Catalogue Number: 2432-0007
• Other Device ID Number: 10885403232329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2018
• 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
• Treatment: BAXTER 1000ML BAG, THERAPY DATE UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR