MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problems Energy Output Problem (1431); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2021

Event Type  malfunction  

Event Description

Machine went into general safe state.Patient not rinsedback.Machine switched out to continue treatment on another machine per rn.

• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS, INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15065067
• MDR Text Key: 296226978
• Report Number: 15065067
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2022,08/04/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2022
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1