MAUDE Adverse Event Report: B BRAUN MEDICAL INC. INFUSOMAT SPACE PUMP IV SET; PUMP INFUSION

Model Number REF#363430

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2018

Event Type  malfunction  

Event Description

After priming the line and upon opening the pressure valve, the valve popped off the tubing and iv medication began to leak out of the tubing.Device will be returned only if manufactures provide prepaid shipping, packaging as per dot, or pick the item up.The details in the report is the extent to which we identify medications involved or patient contact.

• Brand Name: INFUSOMAT SPACE PUMP IV SET
• Type of Device: PUMP INFUSION
• Manufacturer (Section D): B BRAUN MEDICAL INC.
• MDR Report Key: 8042157
• MDR Text Key: 126508742
• Report Number: MW5081070
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2018

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: No Information
• Device Model Number: REF#363430
• Device Lot Number: 0061635198
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR