MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problems No Display/Image (1183); Protective Measures Problem (3015); Unexpected Shutdown (4019)

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

Event Date 07/03/2020

Event Type  Injury  

Event Description

Dialysis machine was running approximately one-hour, final conductivity alarm started, then pressure sensor malfunction alarm then system failure alarm started, and machine stopped running and screen went blank.Patient manually reinfused completely.Work order placed.New machine set up and patient received complete treatment with no blood loss.

• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 10459608
• MDR Text Key: 204549971
• Report Number: 10459608
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2020
• Event Location: Other
• Date Report to Manufacturer: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 14235 DA
• Patient Weight: 81