MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA ACCESS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MMC2071B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 06/22/2015

Event Type  Injury  

Event Description

It was reported that a patient experienced an air embolism coincident with the use of a blood administration set.The cause of the air in line was not reported.The patient was post-surgery, receiving a fluid bolus of hartmann¿s solution (compound sodium lactate) via the intravenous (iv) set into a peripheral vein.It was the second 250 ml fluid bolus from the same 500 ml bag.The solution bag was under pressure in a pressure bag.After receiving the bolus of hartmann¿s solution, it was reported that the patient collapsed, became tachypneic, oxygen desaturated and had a drop in blood pressure.This happened after a bubbling sound was heard by the nurse and the nurse noticed that the solution was finished and air had run down the line into the patient¿s catheter.There was no leak noted on the iv set and no disconnection had occurred.The patient was treated for the event with unspecified medication for blood pressure, increased oxygen, and insertion of a central venous line.On an unreported date, the patient recovered from the air embolism.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; a47 industrial estate, malta b; marsa ; MT
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate, malta b; marsa ; MT
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4924113
• MDR Text Key: 6032188
• Report Number: 1416980-2015-29390
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: MMC2071B
• Device Lot Number: 14H31V469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2015
• Initial Date FDA Received: 07/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HARTMANN'S SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 50