FDA Adverse Event Malfunction Summary report: N

AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1821830 · Received August 31, 2010

Report

Report Number: 1423500-2010-03027
Event Type: Malfunction
Date Received: August 31, 2010
Date of Event: August 1, 2010
Report Date: August 9, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS PERFORMED WITH NO DEFECTS NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Additional Manufacturer Narrative · 1

(B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

DISLOCATION.

Description of Event or Problem · 1

A REPORT WAS RECEIVED VIA THE CORPORATE MAILBOX THAT A HOME PATIENT'S (HP) CAREGIVER REPORTED A CASSETTE THAT DRAINED FLUID BEFORE IT SHOULD HAVE BEEN. PRODUCT SURVEILLANCE CONTACTED THE HP'S MOTHER REGARDING THE REPORTED CONDITION. THE HP'S MOTHER STATED FLUID WAS LEAKING, BUT SHE WAS NOT SURE OF THE LOCATION OF THE LEAK. THE SAMPLE WAS DISCARDED. NOTHING UNUSUAL ABOUT THE SET WAS REPORTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. WRITER ASKED THE HP' MOTHER TO RETAIN A SAMPLE SHOULD THE PROBLEM RECUR. NO ADDITIONAL INFORMATION PROVIDED AT THE TIME OF THIS CALL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOMATED PD SET W/CASSETTE4 PRONG	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME		H09K17060

Patients

Seq	Age	Sex	Outcome	Treatment
1	3 YR