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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)
Event Date 02/05/2021
Event Type  Death  
Manufacturer Narrative
Event site postal code - (b)(6).Initial reporter name - (b)(6) additional initial reporter information - (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed.When the clinical user selected "help" a "unit overheating" message appeared.The intra-aortic balloon pump (iabp) was swapped for another to finish the procedure.Patient had expired due to poor prognosis.Immediate cause of death: cardiogenic shock.Antecedent causes: myocardial infarction.The patient went into cardiogenic shock, arrested, ventricular fibrillation (vf), defibrillated, pulseless electrical activity (pea) and cardiopulmonary resuscitation (cpr) x 10 minutes.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period (b)(6) 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Complaint record id # (b)(4).H3 other text: device not returned.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarmed.When the clinical user selected "help" a "unit overheating" message appeared.The intra-aortic balloon pump (iabp) was swapped for another to finish the procedure.Patient had expired due to poor prognosis.Immediate cause of death: cardiogenic shock.Antecedent causes: myocardial infarction.The patient went into cardiogenic shock, arrested, ventricular fibrillation (vf), defibrillated, pulseless electrical activity (pea) and cardiopulmonary resuscitation (cpr) x 10 minutes.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).
 
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Brand Name
UNKNOWN INTRA-AORTIC BALLOON
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key11375939
MDR Text Key233434777
Report Number2248146-2021-00139
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARDIOSAVE/CH277514D8; CARDIOSAVE / (B)(4)
Patient Outcome(s) Death;
Patient Age70 YR
Patient Weight84
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