MAUDE Adverse Event Report: FRESENIUS BLOOD PUMP ROTOR; ACCESSORIES, HEMODIALYSIS

Catalog Number M30990

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Cut In Material (2454)

Patient Problem Blood Loss (2597)

Event Date 03/10/2018

Event Type  Injury  

Event Description

Patient was on dialysis.During the treatment, the blood pump tubing developed a leak, from scrapping of the tubing wall from a loose tubing guide on the pump rotor.

• Brand Name: BLOOD PUMP ROTOR
• Type of Device: ACCESSORIES, HEMODIALYSIS
• Manufacturer (Section D): FRESENIUS; waltham MA 02451
• MDR Report Key: 7348119
• MDR Text Key: 102894533
• Report Number: MW5075925
• Device Sequence Number: 1
• Product Code: KOC
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M30990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 73