MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA UNKNOWN; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

On 11 jun 2012, an email notification of a leak was received in the baxter healthcare corporate mailbox.A baxter-associate notified baxter corporate product surveillance of a defective peritoneal solution bag which was found in the icu unit at (b)(6) medical center.The central supply supervisor was notified that the bag was leaking.On 30 jul 2012, additional information was obtained stating that the defective peritoneal solution bag had the following national drug code (noc # 492302069) and lot # 115004009.On 21 aug 2012, a internet search was conducted and noc number was identified for 49230-0206-92 as oelflex low magnesium, low calcium dextrose dialysis solution, 2000 mis in a 2 liter bag manufactured by fresenius medical care north america.Fda application number (b)(4).It is unknown whether there was patient involvement, patient injury or necessary medical intervention.No additional information is available.Patient injury reported: yes, medical intervention required: yes (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA
• MDR Report Key: 17533119
• MDR Text Key: 321242828
• Report Number: MW5140024
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1