FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 2881896 · Received December 20, 2012

Report

Report Number: 1416980-2012-07798
Event Type: Malfunction
Date Received: December 20, 2012
Date of Event: November 27, 2012
Report Date: November 27, 2012
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: FRN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE UNFILLED UNIT. THE REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. A LEAK TEST SHOWED NO SIGNS OF LEAKAGE ON ANY PART OF THE DEVICE. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. THIS PRODUCT IS NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

Description of Event or Problem · 1

BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR LEAKED AT THE FILL PORT DURING FILLING. THE DEVICE WAS BEING FILLED WITH A SOLUTION OF ROPIVACAINE HYDROCHLORIDE HYDRATE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSOR	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		12E031

Patients

Seq	Age	Sex	Outcome	Treatment
1