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

Catalog Number 4C8723

Device Problem No Flow (2991)

Patient Problem Bradycardia (1751)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that ¿several¿ patients have experienced significant bradycardia due to no flow or restricted flow occurring during infusions in which a clearlink tubing set was used.The tubing sets were being used with unspecified pumps.It was reported that when an infusion was being run at a low rate, the pump alarm ¿does not go off until late¿ and therefore, does not sense early on if the infusion is running correctly resulting to patient not getting medication.As a result this has resulted in patient reactions such as significant bradycardia and clinicians not being able to inject drugs into the patients (no further detail was provided).No further information could be obtained such as how many patients this occurred with, what medical interventions were required, what drug was being infused and/or the patients outcomes from the events.No additional information is available.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE-CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE-CARTAGO; baxter healthcare-cartago; ni; cartago ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5884199
• MDR Text Key: 52380039
• Report Number: 1416980-2016-14260
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/17/2016

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: 4C8723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/17/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening