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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Pumping Stopped (1503); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2020
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 company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.The stm replaced the scroll compressor as it was near replacement interval of 5000 hours and as a precaution.Unit passed all calibration, functional and safety tests.Unit was returned to customer and cleared for clinical use.The scroll compressor will be returned to our national repair center for failure investigation, and a supplemental report will be submitted upon completion of this investigation.
 
Event Description
I was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) displayed "system over temperature" on screen and pump stopped.There was no harm or injury to the patient and no adverse event was reported.
 
Manufacturer Narrative
The suspected faulty scroll compressor was sent to getinge's national repair center (nrc) for evaluation.A senior repair technician inspected the scroll compressor and no visual damage was observed.The national repair center installed the compressor into the cardiosave test fixture and tested the compressor to factory specifications per the cardiosave service manual with a known good temperature probe installed into the compressor, a cardiosave trainer set at 130 beats per minute in the normal sinus rhythm mode and two depleted batteries installed into their respective slots 1 and 2.A 40cc balloon was used.An autofill was initiated and pumping began.The cardiosave pumped for one day when the national repair center adjusted the cardiosave trainer into the atrial fib mode which would put more stress on the compressor.A day later the cardiosave was manually shut down.The national repair center could not verify the failure of over temperature message on the display after the cardiosave pumped for 52 hours, 45 minutes.The compressor passed testing.The compressor was sent to research and development for further failure analysis.The national repair center received the scroll compressor from research and development r&d).R & d stated that the compressor was run over two nights using afib trigger mode and at 130 bpm using an engineering temperature sensor.Both trigger modes produced very similar temperature profiles with a max temperature of 65.1 °c, well below the over temperature limit of 80 °c.The compressor passed testing.The scroll compressor was retained in the national repair center per procedure.
 
Event Description
I was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) displayed "system over temperature" on screen and pump stopped.There was no harm or injury to the patient and no adverse event was reported.
 
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Brand Name
CARDIOSAVE HBRID TYPE B PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10201340
MDR Text Key196750838
Report Number2249723-2020-00984
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/04/2020
Initial Date FDA Received06/26/2020
Supplement Dates Manufacturer Received07/21/2020
Supplement Dates FDA Received08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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