FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 17912581 · Received October 11, 2023

Report

Report Number: 1416980-2023-05151
Event Type: Malfunction
Date Received: October 11, 2023
Date of Event: September 15, 2023
Report Date: November 13, 2023
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

H10: 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.

Additional Manufacturer Narrative · 0

D4: LOT #: DR23NE4055 IS NOT RECOGNIZED BY BAXTER. G1 MANUFACTURING FACILITY - THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: BAXTER HEALTHCARE - MOUNTAIN HOME 1900 N HIGHWAY 201 MOUNTAIN HOME, AR 72653 UNITED STATES. BAXTER HEALTHCARE - DOMINICAN REPUBLIC (B)(4) KM 18.5, PARQUE INDUSTRIAL ITABO, (B)(4) SAN CRISTOBAL 91000 DOMINICAN REPUBLIC. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 0

IT WAS REPORTED THAT AN INTEGRATED APD SET W/CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING PRIMING OF THE DEVICE FOR 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
1179971	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE CORPORATION	NA	DR23NE4055

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown		HOMECHOICE CLARIA DEVICE\| UNSPECIFIED PD SOLUTION