FDA Adverse Event Malfunction Summary report: N

NI

MDR report key: 19933121 · Received August 7, 2024

Report

Report Number: 1416980-2024-04110
Event Type: Malfunction
Date Received: August 7, 2024
Date of Event: July 15, 2024
Report Date: August 7, 2024
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: FKX
PMA / PMN Number: NI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

G1: THE DEVICES WERE MANUFACTURED AT ONE OF THE FOLLOWING FACILITIES: BAXTER HEALTHCARE - MOUNTAIN HOME 1900 N HIGHWAY 201 MOUNTAIN HOME AR 72653 UNITED STATES. BAXTER HEALTHCARE - DOMINICAN REPUBLIC CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA HAINA, SAN CRISTOBAL 91000. DOMINICAN REPUBLIC THE DEVICES WERE 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT TWO (2) HOMECHOICE CASSETTES LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
580114	NI	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE CORPORATION	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		HOMECHOICE\| UNSPECIFIED PD SOLUTION BAG