MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA SOLUTION OR BLOOD ADMIN.SET; SET, BLOOD TRANSFUSION

Catalog Number RMC9622P

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a blood administration set had damaged or crushed tubing.There was no patient involvement and no additional information is available.

Manufacturer Narrative

(b)(4).The actual device was not available; however, a photograph of the sample was provided for evaluation.A batch review was conducted and found that this lot was produced on a new packaging machine which is the root cause of this malfunction.A capa was opened to address this issue and found that a sensor was missing from the new packaging machines.As of april 2015 the sensors have been installed and a 100% visual inspection implemented to prevent further malfunctions.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SOLUTION OR BLOOD ADMIN.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: 4908680
• MDR Text Key: 18660775
• Report Number: 1416980-2015-28492
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: RMC9622P
• Device Lot Number: 15C01V847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2015
• 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