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

Catalog Number 110655

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Discomfort (2330)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that one hour into treatment with an ak96 control unit, a patient experienced chest tightness, increased in blood pressure and discomfort and the machine triggered an abnormal electrical conductance and the venous pressure high alarms.The machine was inspected and it showed that the dehydration was correct.The patient was treated with dexamethasone (5mg, intravenous bolus) and xintongding (10mg, orally).Thirty minutes later, the machine again triggered the same alarms and patient symptoms were not improved.Treatment was immediately stopped and heparin was used to "circulate the tube".The patient's weight was observed to have increased (inverse ultrafiltration).Exact weight measurement was not provided.Treatment was switched to another machine and the patient was put on oxygen (3l/min) and ecg monitoring.Symptoms was reported to have improved and treatment was completed.No additional information is available.

Manufacturer Narrative

B5: it was reported that when treatment was discontinued, blood was returned to the patient.H10: the device was evaluated onsite by a hospital engineer and a malfunction was observed and repaired.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 96
• 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 ; 2242702068
• MDR Report Key: 12622680
• MDR Text Key: 276100933
• Report Number: 9616026-2021-00057
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female