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

Model Number 2426-0500

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Dyspnea (1816); Nausea (1970); Tachycardia (2095); Diaphoresis (2452); Low Oxygen Saturation (2477)

Event Date 05/28/2016

Event Type  Injury  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that a heparin infusion had multiple air in line alarms on (b)(6) 2016.On (b)(6) 2016 at 0530 the patient presented suddenly with shortness of breath, diaphoresis, tachycardia, nausea and oxygen saturation in the 80's.Interventions included oxygen by partial non rebreather, zofran iv push, lab tests and ekg.The patient recovered for a short time, however symptoms returned and worsened at 0650 and the patient was transferred to the icu where further interventions included a chest ct, abg's, bipap, and iv lasix.The left antecubital iv site which had been disconnected and used for the ct contrast injection was noted to have blood return however leaked at the insertion site when flushed and was discontinued.The ct scan result indicated, "prominent nondependent gas bubbles within the included portions of the left axillary and subclavian vein and innominate vein and right ventricle.These may be iatrogenic in origin, related to excessive air/bubbles within a left upper extremity iv site.Possibility of infection at or near the iv site by a gas-forming organism could also be considered.".

• 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: 5745932
• MDR Text Key: 48064435
• Report Number: 9616066-2016-00855
• 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
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 8100,8015, THERAPY DATE (B)(6) 2016
• Patient Outcome(s): Required Intervention