FDA.reportPublic FDA data

MAUDE MDR 7074823

MDR report key
7074823
Report number
3007697864-2017-00069
Event key
0
Event type
3
Date received
2017-12-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
Phone
224-224-2242
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MARSAPPARATUS, HEMOPERFUSION, SORBENTBAXTER HEALTHCARE - ROSTOCKFLDNA8004730000022763Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-010

Event Narratives#

N

Patient 1

THE ISSUE OCCURRED ON AN UNREPORTED DATE IN 2017. TELEPHONE NUMBER: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

WHILE FILLING A MARS KIT WITH AN UNSPECIFIED SOLUTION, IT WAS NOTICED THAT THE CONNECTION OF UNIT 4 TO THE BLOOD DIALYZER WAS PARTLY UNGLUED, WHICH CAUSED THE UNIT TO LEAK (NO FURTHER DETAIL WAS PROVIDED). THE ISSUE OCCURRED PRIOR TO USE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

N

Patient 1

MDR 3007697864-12/12/2017-001-R. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE LINE WAS DETACHED FROM THE HANSEN CONNECTOR AT UNIT 4. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE AN INSUFFICIENT GLUING OF THE CORRESPONDING LINE TO UNIT 4 DURING THE MANUFACTURE OF THE SET. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.