INTEGRATED APD SET W/CASSETTE3-PRONG

Report

Report Number: 1423500-2010-06029
Event Type: Injury
Date Received: November 20, 2010
Date of Event: October 1, 2010
Report Date: October 27, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10G15043, H10H16015, H10H11107, AND H10H28044) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

Additional Manufacturer Narrative · 1

(B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. THIS IS REPORT 1 OF 6 FOR THIS PERITONITIS EPISODE.

Description of Event or Problem · 1

IT WAS REPORTED TO BAXTER (B)(4) THAT 2 INFUSOR LV 100 DEVICES WERE LEAKING BEFORE USE. THIS IS REPORT NUMBER 1 OF 2. THE DEVICES WERE FILLED WITH 90 MILLIGRAMS PAMIDRONATE WHEN THE LEAKS WERE OBSERVED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Description of Event or Problem · 1

DURING FOLLOW-UP FOR AN UNRELATED ISSUE, THE PATIENT'S NURSE INDICATED THE PATIENT WAS BEING TREATED FOR PERITONITIS. THE NURSE STATED THE PATIENT NEEDED TO HAVE ANOTHER DOSE OF ANTIBIOTICS AND WAS CONTINUING WITH THERAPY. THE NURSE STATED THE PATIENT HAS NOT REPORTED ANY SYMPTOMS. THE NURSE STATED THE PATIENT WAS DOING WELL WITH THE FOLLOWING TREATMENTS. THE NURSE THEN STATED SHE DID NOT WANT TO BE CONTACTED ABOUT THE PATIENT AND NO OTHER INFORMATION WOULD BE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTEGRATED APD SET W/CASSETTE3-PRONG	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention