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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Inability to Auto-Fill (1044); Break (1069); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge field service engineer (fse) was dispatched to investigate. The fse performed full testing and calibrations and found that the iabp was working to specifications. The fse was unable to replicate the reported failure. The fse requested bts to do the electrical safety testing before handover. The iabp unit was cleared for clinical use.
 
Event Description
It was reported that a cardiosave intra-aortic balloon pump (iabp) was used on a patient with heart failure during transfer to (b)(6). A sensation plus 50cc intra-aortic balloon (iab) catheter was inserted in the right femoral artery (raf) and connected to fiber-optic with arterial line flush connected to a catheter. The patient was transferred to icu and the iabp was plugged into ac power. The patient was then transferred from (b)(6) hospital onto a (b)(6) plane/aircraft. The ccl nurse checked the placement of the catheter in the patient's groin before departing and the iabp was functioning normally. After approximately 30-40mins into the flight, the iabp unit was attempting to autofill and the unit went into standby mode. The nurse pressed the start button to re-commence pumping. The unit auto-filled and began pumping appropriately. The iabp went into standby mode again and had to be re-started. This occurred multiple times and the nurse noticed that the helium supply was draining quite quickly. The nurse checked the patient's groin, catheter tubing, connection of catheter into pump and all extension connections. There was no leak alarm or kink catheter alert throughout this period. There was no loose connections or blood/fluid observed in the catheter tubing. The nurse noted that the helium drained quickly, over a 20 minute period and then the unit went to standby mode. The catheter was disconnected from the iabp and manually inflated/deflated for the remainder of the trip to (b)(6). When the plane arrived at the airstrip, the patient was unable to be reconnected to the (b)(6) iabp unit, as the catheter was damaged from the syringe during the manual inflations. Following the event, the patient¿s condition was reported as stable and no adverse event reported.
 
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Brand NameCARDIOSAVE
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 Key7959982
MDR Text Key123829449
Report Number2249723-2018-01766
Device Sequence Number0
Product Code DSP
Reporter Country CodeAS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-31
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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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