MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. INTERLINK; SET, BLOOD TRANSFUSION

Model Number 2C6700

Device Problem Backflow (1064)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2022

Event Type  malfunction  

Event Description

Blood was hung utilizing blood tubing.All clamps were open, most importantly clamp to central line.The bottom port (where you can attach a secondary primary tubing) was capped with the green alcohol caps.Blood back flowed out of this port onto patient and bed.Estimated 22cc of blood came out of port (according to pump).Nothing is supposed to come out of ports, one way channel when syringes are not attached.Rest of blood in tube was transferred back into blood bag, new tubing was utilized with no problem.Psm (patient service manager) was notified and has tubing with her.

• Brand Name: INTERLINK
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 13450769
• MDR Text Key: 285046971
• Report Number: 13450769
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2022

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: Health Professional
• Device Model Number: 2C6700
• Device Catalogue Number: 2C6700
• Device Lot Number: R21E27114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other