FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 4100010 · Received September 18, 2014

Report

Report Number: 1416980-2014-32065
Event Type: Malfunction
Date Received: September 18, 2014
Date of Event: August 26, 2014
Report Date: August 26, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: FRN
PMA / PMN Number: K910425
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EI
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THIS LOT WAS MANUFACTURED FROM MARCH 24, 2014 TO MARCH 25, 2014. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED AN ELONGATED BLACK PARTICLE, APPROXIMATELY 2.03 MM LONG, FLOATING IN THE BLADDER. A FOURIER TRANSFORM INFRARED SPECTROSCOPY SCAN DETERMINED THAT THE PARTICULATE WAS BUTYL RUBBER. THE CAUSE OF THE PARTICULATE COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SMALL VOLUME INTERMATE HAD A LARGE BLACK PARTICLE FLOATING IN THE FLUID OF ITS BLADDER. THIS WAS FOUND AFTER FILLING THE DEVICE WITH MEROPENEM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
577763	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		14C061

Patients

Seq	Age	Sex	Outcome	Treatment
1