FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 3853203 · Received June 6, 2014

Report

Report Number: 1416980-2014-18151
Event Type: Malfunction
Date Received: June 6, 2014
Date of Event: April 29, 2014
Report Date: May 13, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
PMA / PMN Number: K071222
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS MANUFACTURED DECEMBER 17, 2013 ¿ DECEMBER 18, 2013. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND MICROSCOPIC INSPECTION SHOWED NO EVIDENCE OF PARTICULATE MATTER IN THE SOLUTION OF THE BLADDER. WHITE STRIATED SPECKS WERE OBSERVED ON THE OUTER SURFACE OF THE INFLATED BLADDER. THE MARKS WERE DETERMINED TO BE ANTIOXIDANT, WHICH IS A COMPONENT OF THE BLADDER MATERIAL. THE DEVICE MET SPECIFICATION AND NO NON-CONFORMANCES WERE OBSERVED DURING EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LARGE VOLUME INFUSOR HAD PARTICULATE MATTER INSIDE THE RESERVOIR. THIS WAS NOTED EITHER DURING OR AFTER FILLING, AND BEFORE PATIENT USE. THE REPORTER STATED THAT THE UNKNOWN SOLUTION HAD BEEN FILTERED BEFORE FILLING THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
332730	INFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE		13N032

Patients

Seq	Age	Sex	Outcome	Treatment
1