MAUDE Adverse Event Report: VITAL SIGNS/ CAREFUSION LIMBO-O CIRCUITS; ANESTHESIA CIRCUITS

Model Number AMN520X4F

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 02/26/2014

Event Type  Injury  

Event Description

"yesterday we have two isolated incidents of an internal leak in the new single limb ge circuits.One occurred in (b)(6) and another at (b)(6) (which i witnessed).In both cases, the preop leak test and machine check was unremarkable.Induction in both cases was uneventful; however, in the middle of both cases, set tidal volumes were unattainable at low flows with mechanical and manual mask ventilation.Adequate tvs could be achieved with high flows.Both machines detected a leak.In both events the circuit was changed out, and this issue was resolved.

Manufacturer Narrative

(b)(4).Carefusion acquired ge vital signs on (b)(6) 2013.A retrospective review of all complaints post acquisition was performed.This complaint was identified as being mdr reportable by cfn standards and is being submitted to the fda.

• Brand Name: LIMBO-O CIRCUITS
• Type of Device: ANESTHESIA CIRCUITS
• Manufacturer (Section D): VITAL SIGNS/ CAREFUSION; 20 campus rd.; totowa NJ 07512
• Manufacturer Contact: jill rittorno ; 75 fairway drive; vernon hills, IL 60061 ; 8472628056
• MDR Report Key: 3836069
• MDR Text Key: 4409802
• Report Number: 2242551-2014-00006
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AMN520X4F
• Device Lot Number: 8882615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention