FDA Adverse Event Malfunction Summary report: N

INFUSOR

MDR report key: 6293458 · Received February 1, 2017

Report

Report Number: 1416980-2017-00789
Event Type: Malfunction
Date Received: February 1, 2017
Report Date: February 24, 2017
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
PMA / PMN Number: K071222
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS MANUFACTURED 16 MAY 2016 - 18 MAY 2016. THE DEVICE WAS RECEIVED FOR EVALUATION CONTAINING APPROXIMATELY 50 ML OF FLUID IN THE BLADDER. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL LEAK TESTING WAS PERFORMED AND REVEALED A LEAK/BACKFLOW FROM THE FILLPORT. FURTHER EXAMINATION REVEALED THAT THE LEAK/BACKFLOW WAS DUE TO A RED COIL CAP SHAVING APPROXIMATELY 2.16 MM IN LENGTH LODGED UNDER THE CHECK-BAND. THE CAUSE OF THE COIL CAP SHAVING COULD NOT BE DETERMINED. A NONCONFORMANCE 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.

Additional Manufacturer Narrative · 1

(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED A LARGE VOLUME INFUSOR LEAKED DURING FILLING WITH AN UNSPECIFIED SOLUTION. THE EVENT OCCURRED BEFORE USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
77831	INFUSOR	PUMP, INFUSION, ELASTOMERIC	MEB	BAXTER HEALTHCARE - IRVINE	NA	16E035

Patients

Seq	Age	Sex	Outcome	Treatment
1