FDA Adverse Event Malfunction Summary report: N

MULTIRATE INFUSOR LV 2,3,5,12PACK FOR JAPAN ONLY

MDR report key: 2030170 · Received March 27, 2011

Report

Report Number: 6000001-2011-02235
Event Type: Malfunction
Date Received: March 27, 2011
Date of Event: March 9, 2011
Report Date: March 9, 2011
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE WAS PRODUCT MISUSE FROM THE CUSTOMER. ADDITIONAL: A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO EXCEPTIONS NOTED DURING THE MANUFACTURING OF THIS DEVICE. CORRECTION: THE FOLLOWING WAS ERRONEOUSLY OMITTED FROM THE INITIAL MEDWATCH: THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

Description of Event or Problem · 1

THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR IN WHICH THE CATHETER WAS SEPARATED FROM THE LUER ADAPTOR. THERE WAS A BREACH IN THE STERILE FLUID PATHWAY. THE EVENT OCCURRED DURING PATIENT USE. THE DEVICE WAS FILLED WITH .25% (B)(4). THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MULTIRATE INFUSOR LV 2,3,5,12PACK FOR JAPAN ONLY	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		10M047

Patients

Seq	Age	Sex	Outcome	Treatment
1				(B)(4)