MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number 20029E

Device Problem Fluid/Blood Leak (1250)

Patient Problems Urinary Retention (2119); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that a filtered medication line leaked at an unspecified location while infusing a diuretic via a syringe pump.This resulted in an increased diuretic regimen because the patient had poor urine output.There was no report of lasting harm.

Manufacturer Narrative

The customer¿s report of a leak was not confirmed.Visual inspection of the set showed no damage or any anomalies.Functional and pressure testing resulted in fluid flowing freely through the set with no leaks or other issues observed.The root cause of the leaking was not identified.

Event Description

The customer reported that a filtered medication line leaked at an unspecified location while infusing a diuretic via a syringe pump.This resulted in an increased diuretic regimen because the patient had poor urine output.There was no report of lasting harm.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7891882
• MDR Text Key: 120822436
• Report Number: 9616066-2018-01736
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 10885403234866
• UDI-Public: 10885403234866
• Combination Product (y/n): N
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8110,30914,SYRINGE, THERAPY DATE UNK
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 3 MO
• Patient Weight: 3