MAUDE Adverse Event Report: BAXTER HEALTHACARE CORPORATION INTERLINK; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number (10)DR19G05045

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Event Description

Rn's attempting to hang blood.Two packages of transfusion tubing missing one of the clamps on the upper end of tubing.Third package okay and blood hung for patient - no adverse impact on patient.

• Brand Name: INTERLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHACARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 9192548
• MDR Text Key: 162342837
• Report Number: 9192548
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: (10)DR19G05045
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30660 DA