NIPRO SET
Received Jul 24, 2003 · Event occurred Jun 28, 2003
Report 8041145-2003-00001 · MDR key 474130
Device
Generic name
Blood Tubing Set
Manufacturer
Nipro (thailand) Corp. Ltd.Model number
A209/V803Catalog number
A209/V808
Lot number
UNK
Product problems
- Alarm, audible
- Failure To Adhere Or Bond
- Leak/Splash
Patient
*
- Transfusion of blood products
- Therapy/non-surgical treatment, aborted/stopped
- Therapy/non-surgical treatment, additional
- Blood pressure, decreased
- Blood Loss
Narrative
Description of Event or Problem
HEMODIALYSIS PATIENT WAS BEING CONNECTED TO DIALYSIS USING A CATHETER ACCESS AND NIPRO BLOODLINES. IT WAS REPORTED THAT THE NURSE HAD DIFFICULTY CONNECTING THE VENOUS CONECTOR (CROSS-THREADED) TO THE CATHETER. NURSE DISCONNECTED AND RECONNECTED WITHOUT DIFFICULTY. APPROXIMATELY 1 HOUR INTO TREATMENT THE MACHINE ALARMED FOR LOW BLOOD PRESSURE. NURSE REMOVED BLANKET FROM PATIENT AND NOTED BLOOD ON BLANKET, PATIENT, CHAIR AND FLOOR. APPROXIMATE BLOOD LOSS OF 500CC. NURSE NOTED BLOOD SEEPING FROM VENOUS CONNECTION OF BLOODLINE AND CATHETER. NURSE RE-SECURED BLOODLINE TO CATHETER AND GAVE 900 CC OF NORMAL SALINE TO PATIENT FOR FLUID REPLACEMENT. PATIENT SEEN BY PHYSICIAN, DIALYSIS TREATMENT DISCONTINUED, AND PATIENT SENT TO THE ER FOR TRANSFUSION.