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

Catalog Number MMC2071B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2014

Event Type  malfunction  

Event Description

It was reported that air was observed in the tubing of an administration set for blood and blood components.Near the end of a sodium lactate (baxter compounded solution) infusion, it was noted that only 1 to 2 cm of fluid was in the set with the rest of the set containing air.The infusion was stopped before the air reached the patient.There was no report of patient injury or medical intervention.No additional information is available.

Manufacturer Narrative

(b)(4).Initial reporter: a second reporter from the same facility with the same phone number was provided: (b)(6).Evaluation summary: the actual device was received for evaluation.Visual inspection and gravity testing were performed.Visual inspection of device did not identify any abnormalities that could have contributed to the reported condition.Gravity testing was performed to check the functionality of the set and roller clamp; the device met the acceptance criteria and passed this test.The reported problem was unable to be verified.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: 4259021
• MDR Text Key: 4990470
• Report Number: 1416980-2014-41181
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MMC2071B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 11/18/2014
• 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: SODIUM LACTATE