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

Catalog Number MMC9609L

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned and an evaluation is complete.Visual inspection was performed and revealed blood through the tubing of the whole set.No clots were observed.The reported condition could not be verified.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a flogard compatible blood set only infused 70 ml after 2.09 hours due to blood clotting below the filter.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: BLOOD RECIPIENT SET
• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5489244
• MDR Text Key: 39980838
• Report Number: 1416980-2016-04812
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2016

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: No Information
• Device Catalogue Number: MMC9609L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 03/09/2016
• 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: BLOOD FOR TRANSFUSION