FDA Adverse Event Death Summary report: N

TRANSFER SET ( MINICAP EXTENDED LIFE PD TRANSFER SET (6") WITH TWIST CLAMP

MDR report key: 18948890 · Received March 20, 2024

Report

Report Number
MW5153017
Event Type
Death
Date Received
March 20, 2024
Date of Event
October 5, 2022
Report Date
March 18, 2024
Manufacturer
BAXTER HEALTHCARE CORPORATION
Product Code
KDJ
UDI-DI
00085412007731
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AL, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

MY HUSBAND, (B)(6), WAS A DIALYSIS PATIENT USING THE HOME CHOICE PRO AUTOMATED PD(PERITONEAL DIALYSIS) SYSTEM FOR 4 YEARS WITH NO PROBLEM. HE HAD A VALVE REPLACEMENT DONE ON (B)(6) 2022, AT (B)(6) HOSPITAL IN (B)(6). THE SURGERY WENT WELL, AND HE DIDN'T NEED A PACEMAKER FOR HIS HEART. HE WAS DISMISSED ON SATURDAY, (B)(6) 2022. AFTER COMING HOME, HE NOTICED HIS PD DRAIN SHOWED SIGNS OF INFECTION, SO HE WAS TOLD TO GO TO THE (B)(6) IN (B)(6) AND BRING A SAMPLE. WHEN THE NURSE CHECKED HIS SAMPLE, IT SHOWED THAT HE HAD PERITONITIS. SO, SHE CALLED HIS HEART DOCTOR BECAUSE HIS HEART RATE AND BLOOD PRESSURE HAD DROPPED. THE HEART DOCTOR HAD THE AMBULANCE TO PICK HIM UP AND DELIVER HIM TO (B)(6). THEY ADMITTED MY HUSBAND IN THE HOSPITAL AND PLACED HIM IN INTENSIVE CARE. MY HUSBAND GOT WORSE, AND HIS HEART RATE KEPT DROPPING. ON THURSDAY (B)(6) 2022, THEY PUT A PACEMAKER IN HIM. THE DOCTOR TOLD ME WHEN HE HAD THE VALVE REPLACEMENT, HE DIDN'T NEED A PACEMAKER BUT FOR SOME REASON THIS TEAM OF DOCTORS THOUGHT HE DID. NOBODY TREATED HIM FOR THE PERITONITIS. AFTER COMING HOME FROM HAVING THE PACEMAKER SURGERY, MY HUSBAND STARTED TO GET WORST AND ON MONDAY, (B)(6) 2022, HE WOKE UP WITH A LOT OF PAIN IN HIS CHEST, HE TOOK A NITROGLYCERIN, AND HE WAS TAKEN TO (B)(6) HOSPITAL BY AMBULANCE. THE DOCTOR AT (B)(6) MEDICAL CENTER CONTACTED HIS HEART DOCTOR IN (B)(6), AND THEY RELEASED HIM BECAUSE HE WAS SCHEDULED TO SEE HIS DOCTOR IN (B)(6) AT 3:00 P.M. ON THIS DAY, WEDNESDAY, (B)(6) 2022, MY HUSBAND PASSED AWAY. THE DOCTORS SAID THEY TRIED TO RESUSCITATE HIM, AND HE TRIED TO COME BACK BUT THE SECOND TIME HE PASSED AWAY. THE DOCTOR WHO DID HIS VALVE REPLACEMENT WAS OUT OF TOWN WHEN MY HUSBAND PASSED AWAY, HE CALLED ME AND SAID HE DIDN'T UNDERSTAND WHAT HAPPEN BECAUSE MY HUSBAND DIDN'T NEED A PACEMAKER, HE WAS DOING REALLY WELL AFTER HIS VALVE REPLACEMENT SURGERY. ON (B)(6) 2022, I RECEIVED A LETTER IN THE MAIL ABOUT AN URGENT DEVICE CORRECTION FROM BAXTER. THE LETTER STATED THAT A DAMAGED OR LEAKING TRANSFER SET COULD RESULT IN MICROBIAL CONTAMINATION OF THE STERILE FLUID PATH, AND THIS MAY PREDISPOSE A PATIENT TO PERITONITIS. THE LETTER FROM BAXTER WAS DATED JANUARY 12, 2022, BUT I DIDN'T RECEIVE THIS LETTER UNTIL AFTER MY HUSBAND PASSED AWAY ON (B)(6) 2022. MY HUSBAND WAS DIAGNOSED WITH PERITONITIS BY HIS DIALYSIS NURSE AT (B)(6) IN (B)(6) BUT WHEN HE WAS TAKEN TO THE (B)(6) HOSPITAL IN (B)(6) , I NEVER SAW THEM REMOVE THE PORT FROM HIS BODY AND TREAT HIM FOR PERITONITIS. WE WERE TOLD WHEN HE DECIDED TO DO PD IN (B)(6) 2018 THAT IF HE GOT AN INFECTION IN HIS PORT, THE PORT SHOULD BE REMOVED. THE DOCTORS AT (B)(6) NEVER REMOVED HIS PORT. I BELIEVE BECAUSE MY HUSBAND WASN'T TREATED FOR PERITONITIS, HE DEVELOPED SEPSIS AND THIS IS WHAT CAUSED HIS DEATH. DATE THE IMPLANT WAS PUT IN: (B)(6) 2018.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
523084 TRANSFER SET ( MINICAP EXTENDED LIFE PD TRANSFER SET (6") WITH TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION 5C4482 00085412007731

Patients

Seq Age Sex Outcome Treatment
1 73 YR Male Hospitalization| D ASPIRIN 81MG.| ATORVASTATIN 10MG.| ATORVASTATIN 10MG.| CEPHALEXIN 500MG.| CIPROFLOXACIN 500MG.| CLINDAMYCIN HCL 300MG.| CLOPIDOGREL 75MG TAB.| FLUCONAZOLE 100MG.| HEART VALVE REPLACEMENT.| HOME CHOICE PRO AUTOMATED PD SYSTEM.| MEDTRONIC AZURE XT DR MRI SURESCAN.| METOPROLOL 25MG 1/2 TAB.| NITROGLYCERIN.| NYSTATIN 5ML SWISH/SWALLOW.| PARICALCITOL 1MG.| PERITONEAL DIALYSIS PORT.| VP-VITE RX TAB.