PULSION PULSIOCATH THERMODILUTION CATHETERS PV2014L16-N

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2014L16-N manufactured by Pulsion Medical Systems Se.

Event Text Entries

[95640937] Further information surrounding the event has been requested and investigation is ongoing. A supplemental medwatch report will be sent when the investigation is completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[95640938] A crack in the luer connection of the catheter has been reported. No clinical consequences occurred. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[120315798] Only one out of five complained products was returned for investigation (see mdr 3003263092-2017-00013). The crack could be confirmed for the returned product. A review of the dhr could not identify any non-conformities or deviations relevant to the reported issue. The same issue appeared in the same hospital five times within three days (see mdr 3003263092-2017-00009, -00010, -00011, and 00013). In all five cases not only the catheter luer lock but also the hub of the needle showed a crack. On the basis of the issue description, as well as on investigation result and experience, it is considered as unlikely that a production error is the root cause. This is supported by the fact that no similar events were reported throughout 2017. The real root cause could not be determined. It is considered as likely that a handling error during use or external force applied by the user have contributed to the events. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[120315799] Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003263092-2017-00012
MDR Report Key7135287
Date Received2017-12-20
Date of Report2018-03-28
Date of Event2017-10-27
Date Mfgr Received2017-12-06
Device Manufacturer Date2017-01-31
Date Added to Maude2017-12-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer StreetPULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21
Manufacturer City85622 FELDKIRCHEN
Manufacturer CountryGM
Manufacturer Phone0498945991
Manufacturer G1CHRISTINA KOEBERL
Manufacturer StreetPULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21
Manufacturer City85622 FELDKIRCHEN
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePULSION PULSIOCATH THERMODILUTION CATHETERS
Generic NamePROBE, THERMODILUTION
Product CodeKRB
Date Received2017-12-20
Catalog NumberPV2014L16-N
Lot Number619480
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeYR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPULSION MEDICAL SYSTEMS SE
Manufacturer AddressPULSION MEDICAL SYSTEMS SE HANS-RIEDL-STR. 21 85622 FELDKIRCHEN GM


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-20

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