FDA Adverse Event Malfunction Summary report: N

INTERMATE

MDR report key: 4243293 · Received November 11, 2014

Report

Report Number: 1416980-2014-39882
Event Type: Malfunction
Date Received: November 11, 2014
Date of Event: October 16, 2014
Report Date: October 16, 2014
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: FRN
PMA / PMN Number: K910425
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS LOT WAS MANUFACTURED FROM JULY 21, 2014 TO JULY 23, 2014. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL AND MICROSCOPIC INSPECTION OF THE DEVICE WAS PERFORMED WITH NO ABNORMALITIES NOTED. THERE WAS NO EVIDENCE OF PARTICULATE MATTER INSIDE OR OUTSIDE OF THE BLADDER/BALLOON OF THE DEVICE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. UPON CONCLUSION OF THE INVESTIGATION, THE REPORTED PARTICULATE MATTER COULD NOT BE VERIFIED AND A CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SMALL VOLUME INTERMATE HAD PARTICULATE MATTER WITHIN ITS BLADDER. THIS WAS FOUND BEFORE USE. THE DEVICE WAS FILLED WITH MEROPENEM, CEFTAZIDIME AND AZTREONAM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
725443	INTERMATE	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - IRVINE		14G030

Patients

Seq	Age	Sex	Outcome	Treatment
1