MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA ACCESS; SET, BLOOD TRANSFUSION

Catalog Number MMC2071B

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/06/2014

Event Type  Injury  

Event Description

It was reported that there was air in the patient¿s administration set.A 1000ml bag of compound sodium lactate had been hung and was being rapidly infused into the patient by use of a pressure bag.After a short amount of time, the drip chamber was observed to be completely empty and air was found to be bubbling up to where the central venous pressure (cvp) line attaches to the cvp port.The air caused an interruption of therapy for the patient resulting in the patient¿s oxygen saturation dropping to 70% and the patient becoming hypotensive.The infusion bag was removed, fio2 was increased to 100% and peep increased to 12cmh2o.Additionally, an increase of milrinone, noradrenaline and adrenaline was given to the patient in addition to fluid to restore the patient¿s blood pressure.Air was aspirated from the lines.The patient¿s saturation increased to 93% over the next 20-30 minutes.No additional information available.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; 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, BLOOD TRANSFUSION
• 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4075814
• MDR Text Key: 4852224
• Report Number: 1416980-2014-30639
• Device Sequence Number: 1
• Product Code: BRZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/15/2014

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 Catalogue Number: MMC2071B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 09/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: COMPOUND SODIUM LACTATE; MILRINONE, NORADRENALINE AND ADRENALINE
• Patient Outcome(s): Required Intervention