MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 96 MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114364

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It was reported an external blood leak was observed originating out of the syringe of the heparin pump of an ak 96 machine.During hemodialysis therapy, the patient was receiving an iron injection via a syringe through the heparin pump.When the iron infusion was complete the syringe popped off ¿automatically¿ and the ak 96 machine triggered an unspecified alarm.The nurse then noted blood flowing out of the syringe.The set was clamped off.The volume of blood lost was 200ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was not received for evaluation; however, the device was evaluated on site by a non-baxter local technician (engineer).The on-site technician did not provide any further information other than the device was repaired.Due to the device not being returned, no further testing could be performed.Therefore, the cause of the condition could not be determined.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 96 MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17558081
• MDR Text Key: 321532128
• Report Number: 9616026-2023-00050
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414112004
• UDI-Public: (01)07332414112004
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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
• Device Catalogue Number: 114364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HEPARIN SYRINGE; IRON SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female