MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GAMCATH; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Catalog Number 103522

Device Problem Disconnection (1171)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 10/23/2020

Event Type  Death  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a four days post surgery, a patient experienced delirium necessitating the initiation of dialysis using a gamcath catheter (inserted in the right jugularis interna).And a non baxter dialysis machine.Ten days later, the venous leg of the shaldon catheter was disconnected, the alarm on the dialysis machine was active and there was a lot of blood in the bed".It was reported that only the bradycardia alarm was active on the monitor since the patient had no arterial pressure monitoring.The patient was apneic with pulseless electrical activity.No resuscitation measures were initiated due to the decision made beforehand to limit therapy.The patient passed away.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot 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: GAMCATH
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10927996
• MDR Text Key: 218949805
• Report Number: 3004367028-2020-00001
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: 103522
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOODLINES: FRESENIUS; CICA DIALYSAT SYSTEM MULTIFILTRATE; FRESENIUS MACHINE; LUER LOCK: KOMBISTOPPER VON BBRAUN; MAL CICA CASETTE; OCTENIDERM; ULTRAFLUX AV DIALYZER; BLOODLINES: FRESENIUS; CICA DIALYSAT SYSTEM MULTIFILTRATE; FRESENIUS MACHINE; LUER LOCK: KOMBISTOPPER VON BBRAUN; MAL CICA CASETTE; OCTENIDERM; ULTRAFLUX AV DIALYZER
• Patient Outcome(s): Death
• Patient Age: 89 YR