FDA Adverse Event Malfunction Summary report: N

NI

MDR report key: 9263123 · Received October 31, 2019

Report

Report Number: 1416980-2019-06047
Event Type: Malfunction
Date Received: October 31, 2019
Report Date: November 27, 2019
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: LHI
PMA / PMN Number: K900585
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS REPORT IS A DUPLICATE OF REPORTS 1937141-2019-0001, 1937141-2019-0002, 1937141-2019-0003, 1937141-2019-0004, 1937141-2019-0005, 1416980-2018-06790, 1416980-2018-07086 AND 1416980-2018-07486. ALL INVESTIGATION ACTIVITIES WILL BE CAPTURED UNDER REPORTS 1937141-2019-0001, 1937141-2019-0002, 1937141-2019-0003, 1937141-2019-0004, 1937141-2019-0005, 1416980-2018-06790, 1416980-2018-07086 AND 1416980-2018-07486. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(6). U.S. FOOD AND DRUG ADMINISTRATION. (2019, SEPTEMBER 17). THE METRIX COMPANY IS RECALLING SPECIFIC LOTS OF EMPTY IV FLEXIBLE CONTAINERS (BAG). ADVERSE EVENT REPORTING NEWS 16(18), 13. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT EIGHT (8) UNSPECIFIED EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED "NEAR THE DIVIDER ROD AND CHANNEL, WHEN THE ROD WAS BEING REMOVED". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1055501	NI	SET, I.V. FLUID TRANSFER	LHI	BAXTER HEALTHCARE CORPORATION	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1