MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. MEDRAD POWER INJECTOR; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Device Problem Disconnection (1171)

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

Event Date 07/12/2018

Event Type  malfunction  

Event Description

Physician wanted a power lv injection using the medrad; however, it repeatedly gave a disconnected and purge message.Several reports have been sent to biomed for repairs and one visit by biomed was supposed to have fixed the problem.This has been an ongoing problem in catheter lab for several months now.Physicians are unable to complete their procedures the way they need to.Medrad injector gave a repeatedly disconnect and purge message.Biomed called in bayer service technician, tech replaced head and calibrated, performed operation verification, returned to service.No harm to patient.

• Brand Name: MEDRAD POWER INJECTOR
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 8027395
• MDR Text Key: 125781727
• Report Number: 8027395
• Device Sequence Number: 1
• Product Code: DXT
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA