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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. The customer has not requested getinge to evaluate the iabp in connection with this event. However, the customer has advised that they have no any additional information to add.
 
Event Description
It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) was not indicating that the fiber optic (fo) catheter was connected. There was no arterial signal or waveform on the iabp. There was no other pump available to switch to so was not able to troubleshoot whether it was the pump or catheter. A getinge representative instructed the customer to disconnect the fo plug and the fluid lumen still did not appear on the screen. The getinge representative, was unable to have the customer switch to another console to check the pump connection because their pumps were all in use with a rental already ordered. The surgeon arrived just when the getinge representative was having the nurse switch to the radial arterial transducer. He ¿flushed it¿ and the arterial line signal appeared and was intact. Afterwards the getinge representative, explained to the nurse about flushing only on standby. There was no patient harm and no adverse event was reported.
 
Event Description
It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) was not indicating that the fiber optic (fo) catheter was connected. There was no arterial signal or waveform on the iabp. There was no other pump available to switch to so was not able to troubleshoot whether it was the pump or catheter. A getinge representative instructed the customer to disconnect the fo plug and the fluid lumen still did not appear on the screen. The getinge representative, was unable to have the customer switch to another console to check the pump connection because their pumps were all in use with a rental already ordered. The surgeon arrived just when the getinge representative was having the nurse switch to the radial arterial transducer. He ¿flushed it¿ and the arterial line signal appeared and was intact. Afterwards the getinge representative, explained to the nurse about flushing only on standby. There was no patient harm and no adverse event was reported.
 
Manufacturer Narrative
The customer has advised that the iabp has been cleared for clinical use.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7964973
MDR Text Key123944410
Report Number2249723-2018-01778
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received11/02/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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