FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 2844776 · Received November 26, 2012

Report

Report Number: 1416980-2012-05805
Event Type: Malfunction
Date Received: November 26, 2012
Date of Event: November 9, 2012
Report Date: November 9, 2012
Manufacturer: BAXTER HEALTHCARE - AIBONITO
Product Code: FRN
PMA / PMN Number: K880733
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

A NURSE HAD CONTACTED HOME CARE SERVICES (HCS) REGARDING A PCA EXTENSION SET WHICH BROKE OFF WHILE A SYRINGE WAS CONNECTED AND THEY LOST ALL THE NARCOTIS. THIS EVENT HAS HAPPENED NUMERIOUS TIMES BEFORE. PRODUCT SURVEILLANCE SPOKE WITH THE CUSTOMER. THE CUSTOMER STATED THAT THE CONNECTION BETWEEN THE CATHETER EXTENSION SET AND THE PREFILLED SYRINGE LUER HAS BROKEN OFF WHILE THE PATIENT WAS CONNETED TO THE SET. THE NURSE CONFIMED THAT ALL THE CONNETION SIGHTS WERE SECURE. THE NURSE STATED THAT THIS HAS BEEN REPORTED TO HER FOR THE PAST TWO WEEKS BUT THINKS IT HAS BEEN HAPPENING LONGER THAN THAT. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCESS	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - AIBONITO

Patients

Seq	Age	Sex	Outcome	Treatment
1