FDA Adverse Event Malfunction Summary report: N

EASYPUMP

MDR report key: 9932985 · Received April 7, 2020

Report

Report Number: 9610825-2020-00074
Event Type: Malfunction
Date Received: April 7, 2020
Report Date: April 7, 2020
Manufacturer: B. BRAUN MELSUNGEN AG
Product Code: MEB
UDI-DI: 04046964448942
PMA / PMN Number: K081905
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). PHOTOS WERE PROVIDED FOR EVALUATION. IN THE PHOTOS A BLACK PARTICULATE CAN BE SEEN FLOATING IN THE SOLUTION, HOWEVER WE WERE UNABLE TO TEST OR MEASURE THE PARTICULATE IN ORDER TO DETERMINE IF THE PARTICULATE COULD HAVE ORIGINATED IN THE MANUFACTURING PROCESS OR IF THE SIZE OF THE PARTICULATE WAS WITHIN THE PRODUCT SPECIFICATIONS. IT SHOULD BE NOTED THAT THIS PARTICULATE WAS IN THE SOLUTION ABOVE THE PRODUCT FILTER, AND THE FILTER WOULD REMOVE ANY PARTICULATE GREATER THAN 1.2¿M. REVIEW OF THE DEVICE HISTORY RECORD PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCE'S OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

Description of Event or Problem · 1

AS REPORTED BY THE USER FACILITY: BLACK FLOATING PARTICLES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
396669	EASYPUMP	PUMP, INFUSION, ELASTOMERIC	MEB	B. BRAUN MELSUNGEN AG	4540040-02	19B03GE671	04046964448942

Patients

Seq	Age	Sex	Outcome	Treatment
1