CXD II

MDR report key: 1823506 · Received September 2, 2010

Report

Report Number: 1423500-2010-03104
Event Type: Injury
Date Received: September 2, 2010
Date of Event: August 1, 2010
Report Date: August 11, 2010
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K895673
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SAMPLE NOT AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). ROOT CAUSE COULD NOT BE DETERMINED. THE CURRENT LABELING WAS FOUND TO BE SUFFICIENT. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

Description of Event or Problem · 1

THIS IS A REPORT BY A NURSE REGARDING PERITONITIS IN A (B)(6) FEMALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. ON (B)(4) 2010 THE PERITONEAL DIALYSIS NURSE REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL FOR APPROXIMATELY ONE MONTH. IT WAS UNKNOWN WHAT REMEDIAL TREATMENT WAS NEEDED. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A CALCIFIED COMMON FEMORAL ARTERY AFTER A PERIPHERAL INTERVENTIONAL PROCEDURE. REPORTEDLY, THE LINK BROKE AND THE DEVICE WAS REMOVED. ANOTHER PROGLIDE WAS USED AND DURING THE ADVANCEMENT OF THE KNOT, IT STALLED. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CXD II	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Hospitalization\| R	5B9766 1.5% LO/CAL UB 2L/2L DNL 5B9770 1.5% LO/CAL