FDA.reportPublic FDA data

MAUDE MDR 6932457

MDR report key
6932457
Report number
3007697864-2017-00055
Event key
0
Event type
3
Date of event
2017-09-14
Date received
2017-10-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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 - ROSTOCKFLDNA80047322763Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-090

Event Narratives#

N

Patient 1

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

D

Patient 1

IT WAS REPORTED THAT DURING PRIMING OF A MARS DISPOSABLE FOR A MARS TREATMENT, THE TUBING WAS FOUND TO BE DISCONNECTED FROM A CONNECTOR, LEADING TO AN EXTERNAL LEAK. THIS OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

N

Patient 1

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 SHOWED THAT THE LINE WAS DETACHED FROM THE HANSEN CONNECTOR. THE HANSEN CONNECTOR WAS FOUND TO BE INSUFFICIENTLY GLUED ONTO THE LINE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A MANUFACTURING ISSUE. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.