FDA.reportPublic FDA data

MAUDE MDR 4921174

MDR report key
4921174
Report number
8010762-2015-00810
Event key
0
Event type
3
Date of event
2015-06-22
Date received
2015-07-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MICHAEL CAMPBELL
Address
KEHLER STRASSE 31 RASTATT 76437 GM
Phone
293-293-2932
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BO-HQV 70600 ADULT PACKMAQUET CARDIOPULMONARY AGDTNVKMO 7100070106.387792131225R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-150

Event Narratives#

D

Patient 1

ACCORDING TO THE CUSTOMER: "USER OBSERVED AN AIR LEAKAGE ON THE HEAT PROBE WHICH IS PLACED IN VENOUS LINE OF THE OXYGENATOR. PROBLEM WAS CONTINUED EVEN THOUGH THE USER HAD DONE ESSENTIAL ACTIONS. NON-CONFORMITY WAS OBSERVED ALMOST AT THE END OF THE SURGERY, AND THE QUESTIONED PRODUCT WAS NOT REPLACED WITH A NEW ONE. NO HARM OCCURRED IN THE PT." (B)(4).

N

Patient 1

MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS WITH SIMILAR MALFUNCTION. DUE TO THIS WE TAKE THESE COMPLAINTS AS AN INPUT TO START AN INTERNAL PROJECT WITH THE INTENTION TO REVIEW ASPECTS OF THE DESIGN, THE MFG PROCESS AND THE TEST METHODS. THIS REVIEW SHOULD COVER ALL POSSIBLE IMPACTS OF THE QUALITY THE VHK71000 RESERVOIR. ADDITIONAL INFO: THE PRODUCT MENTIONED IS A TUBING SET WITH RESERVOIR AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE RESERVOIR WHICH IS REGISTERED UNDER 510 (K): K102919.