FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 3812383 · Received May 15, 2014

Report

Report Number: 1416980-2014-15580
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 24, 2014
Report Date: April 24, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EI
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LOT 13G023 WAS MANUFACTURED JULY 10, 2013 - JULY 12, 2013. VISUAL INSPECTION OF THE INFUSOR UNIT (VIA THE NAKED EYE) SHOWED NO EVIDENCE OF FLOW AT THE DISTAL LUER WHEN THE LUER CAP WAS REMOVED. A FUNCTIONAL TEST COULD NOT BE PERFORMED BECAUSE A NO FLOW PROBLEM WAS OBSERVED DURING THE VISUAL INSPECTION OF THE INFUSOR UNIT. FURTHER VISUAL INSPECTION (VIA THE NAKED EYE) REVEALED THE CAUSE OF THE NO FLOW PROBLEM WAS DUE TO CRYSTALLIZED DRUG BLOCKING THE FLUID PATH AT THE DISTAL END OF THE GLASS CAPILLARY. SINCE THE NO FLOW PROBLEM WAS CAUSED BY CRYSTALLIZED DRUG AND NOT BY THE INFUSOR UNIT ITSELF, THE INFUSOR UNIT IS DETERMINED TO HAVE MET PRODUCT SPECIFICATION AND IS THEREFORE A CONFORMING PRODUCT. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

DURING A SAMPLE EVALUATION PERFORMED ON AN INFUSOR ELASTOMERIC DEVICE, A NO FLOW WAS OBSERVED AT THE DISTAL LUER WHEN THE LUER CAP WAS REMOVED. THIS OBSERVATION WAS MADE VISUALLY. THIS OBSERVATION WAS MADE OUTSIDE OF PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291665	INFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		13G023

Patients

Seq	Age	Sex	Outcome	Treatment
1