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

Catalog Number JC7790

Device Problems Improper Flow or Infusion (2954); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a blood recipient set had collapsed and was half-filled with air.The set was connected to a baxter infusion pump with an infusion rate of 140 cc/hr administering "culot globulaire num 2".It was further reported the set was primed correctly and all air bubbles were initially removed.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information : the actual device was not available; however, a photograph of the unused sample was provided for evaluation.Visual inspection of the photograph of the unused sample did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8920883
• MDR Text Key: 155218992
• Report Number: 1416980-2019-04573
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JC7790
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: "CULOT GLOBULAIRE NUM 2"; COLLEAGUE PUMP