FDA.reportPublic FDA data

MAUDE MDR 5972617

MDR report key
5972617
Report number
8010762-2016-00588
Event key
0
Event type
3
Date of event
2016-08-16
Date received
2016-09-23
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
1BE-HQV 33800#COMPLETE PACKFILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINEMAQUET CARDIOPULMONARY AGDTMBE-0017570100250392189712Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-230

Event Narratives#

N

Patient 1

(B)(4). MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED. THE TESTED PRODUCTS HAS THE SAME LEAKAGE AT THE SAME POSITION. THIS COULD BE DETERMINED AS BONDING FAILURE. VISUAL INSPECTION, TIGHTNESS TEST ACC. TO LV 203 AND TIGHTNESS TEST WITH ROLLER PUMP HAVE BEEN PERFORMED. RESULTS: DURING TIGHTNESS TEST ACC. TO LV 203 THE EXACT POSITION OF THE LEAK IN THE ARTERIAL FILTER BETWEEN THE COVER AND THE HOUSING COULD BE DETECTED (IMPROPER ULTRASONIC WELDING). DURING TESTING WITH ROLLER PUMP LEAKAGE AT QUART COULD ALSO BE DETECTED BUT THE EXACT POSITION WAS NOT FOUND DURING THIS KIND OF TEST. THE EXISTING LIQUID COLLECTED AT THE LOWEST POINT OF THE FILTER AND DRAINED. MOST POSSIBLE ROOT CAUSE COULD BE THE BAD BONDING BETWEEN COVER AND FILTER BODY. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

D

Patient 1

IT WAS REPORTED THAT PRIME A LEAK OCCURRED AT BY OPENING THE BYPASS. NO KNOWN CONSEQUENCES TO THE PATIENT WERE REPORTED. (B)(4).