FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3081030 · Received April 26, 2013

Report

Report Number: 1416980-2013-10527
Event Type: Malfunction
Date Received: April 26, 2013
Date of Event: April 1, 2013
Report Date: April 1, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE EVENT OCCURRED BEFORE USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION: DURING FOLLOW-UP WITH THE CUSTOMER, IT WAS IDENTIFIED THAT THE CUSTOMER HAD INCORRECTLY REPORTED THE EVENT. ORIGINALLY THE CUSTOMER THOUGHT THAT THE SUPPLIES WERE MISSING CAPS, HOWEVER, ALL OF THE SUPPLIES DID HAVE CAPS PRESENT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WERE THIRTY CASSETTES THAT WERE MISSING CAPS. THE EVENT OCCURRED BEFORE USE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 8 OF 30 ASSOCIATED WITH THIS LOT NUMBER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
182874	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME		H13B04102

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR			HOMECHOICE