MAUDE Adverse Event Report: ZEVEX, INC. CURLIN PUMP; TOTAL PARENTERAL NUTRITION PUMP

Model Number 6000CMS

Device Problems Device Alarm System (1012); Detachment Of Device Component (1104)

Patient Problems Air Embolism (1697); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 01/10/2017

Event Type  Injury  

Event Description

Reporter stated that she experienced a life threatening situation when the clamp of the baxter bag came off and allowed air to get into the sterile bag then eventually into her.As a result she suffered from air embolism and was transported to the emergency room by an ambulance.She also said that the tpn pump sensor is supposed to detect air coming into the system but it failed to do that.The reporter said she also experienced tachycardia, hypotension and sever chest pain.She was treated at the emergency room and released after 6 hours.

• Brand Name: CURLIN PUMP
• Type of Device: TOTAL PARENTERAL NUTRITION PUMP
• Manufacturer (Section D): ZEVEX, INC.
• MDR Report Key: 6629634
• MDR Text Key: 77296376
• Report Number: MW5070267
• Device Sequence Number: 1
• Product Code: FRN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/08/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 6000CMS

Device Lot Number

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Weight: 68