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

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

Patient Problems Abdominal Distention (2601); Swelling/ Edema (4577)

Event Date 07/06/2021

Event Type  Injury  

Event Description

It was reported that during treatment with an ak 96 machine, a transmembrane pressure (tmp) alarm was generated as the tmp was negative at 65 mmhg, indicating backfiltration was likely occurring.The dialysis system was checked and the tmp alarm limits were adjusted.The tmp decreased to -35 mmhg.It was reported this event occurred several times.Twenty-four (24) minutes later the patient complained of abdominal distension and facial edema was observed.The treatment was interrupted and the post treatment weight was reported to be 64kg.Indicating that the patient had gained 11 kg during the elapsed treatment time.The patient was treated with isolated ultrafiltration during which 6000ml fluid was removed.The blood pressure was recorded as 103/77 mmhg at completion of the treatment.And the patient recovered.No additional information is available.

Manufacturer Narrative

Facility name: (b)(6) medical university.Phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.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: 12898208
• MDR Text Key: 283517454
• Report Number: 9616026-2021-00070
• Device Sequence Number: 1
• Product Code: KDI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 12/29/2021
• 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: FISTULA NEEDLE 16G 25 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 53 KG