MAUDE Adverse Event Report: BBRAUN ACCUFLO

Model Number ACCUFLO

Device Problem Connection Problem (2900)

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

Event Date 09/30/2015

Event Type  malfunction  

Event Description

Approximately 2 months ago, an accuflo 250 ml volume, 167 ml/hr rate elastomeric device, lot #15b11gf 141, was found to be missing a screw top, so the pump tubing could not be attached.This accuflo was not used on a patient.This occurred at the (b)(6) site.

• Brand Name: ACCUFLO
• Type of Device: ACCUFLO
• Manufacturer (Section D): BBRAUN; bethlehem PA 18018
• MDR Report Key: 5263910
• MDR Text Key: 32672775
• Report Number: MW5058253
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/30/2015

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: ACCUFLO
• Device Catalogue Number: CT-1670-250
• Device Lot Number: 15B11GF 141
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1