FDA.reportPublic FDA data

MAUDE MDR 7138656

MDR report key
7138656
Report number
8010762-2017-00406
Event key
0
Event type
3
Date of event
2017-11-02
Date received
2017-12-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 76437 RASTATT GM
Phone
497-497-4972
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1QUART ARTERIAL FILTER WITH SOFTLINE COATINGFILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINEMAQUET CARDIOPULMONARY AGDTMHBF 140-J70103161770112831* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-210

Event Narratives#

N

Patient 1

(B)(4). MAQUET GETINGE GROUP IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED. WE TESTED THE RETURNED FILTER IN OUR LABORATORY, FOLLOWING OUR STANDARD PROCESS, ON TIGHTNESS. THEREFORE, THE QUART WAS TESTED AT BELOW WATER IN A WATER BATH AND WAS THEN PRESSURIZED WITH COMPRESSED AIR (0.3 BAR). DUE TO THE AIR ESCAPING (VISIBLE AS AIR BUBBLES IN WATER) A LEAKAGE IN THE WELDING COVER HAS BEEN FOUND. THE LEAKAGE AT THE CONNECTION BETWEEN COVER AND FILTER BODY CAN BE CONFIRMED. MOST POSSIBLE ROOT CAUSE COULD BE THE BAD WELDING BETWEEN COVER AND FILTER BODY. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS AN SYSTEMIC ERROR. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY.

D

Patient 1

CUSTOMER REPORTED THAT "DURING PRIMING AT (B)(6), IT WAS NOTED THAT THE PRIMING SOLUTION WAS LEAKING FROM THE UPPER SIDE OF THE QUART." NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4).