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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Device Alarm System (1012); Inflation Problem (1310)
Patient Problem Loss of consciousness (2418)
Event Date 01/14/2019
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided. Additional information on this complaint event is being requested; a supplemental report will be submitted, if necessary. Full name of event site: (b)(6) university hospital.
 
Event Description
(b)(4) received a report from a patient who received cardiosave intra-aortic balloon pump (iabp) therapy as follows: "i am a recent iabp patient. On (b)(6) 2019 my pump failed and i was urgently rushed to the operating room. I am looking for information on how this pump could fail and put my life in danger. I was not contacted by any maquet rep or told what happened. I will be contacting the fda and perhaps the media and or attorney to make sure this gets the attention it deserves. It is my understanding that in 30 days 3 different patients had over ten failures. Please advise. " medwatch# mw5085074 received on 01-apr-2019 with the following information: "maquet femoral balloon pump was placed in the right leg on 2019 and was scheduled to have the axillary pump placed on monday 2019. On 2019 (sunday) approx 7:30 pm, the balloon pump started beeping. It took several people to make it start working again. Just after midnight, the pump started going off again, so many people tried to fix and/or figure out what was wrong. Dr happened to have been called in for another emergency and he came in. He did all he could think of and even called the rep (dr said that the rep thought there may be "micro-tear" in the balloon). I believe, from what i could gather, the pump wouldn't fill them helium. So, dr went back and forth with the decision to take out and replaced, or take it out and wait the 6 hrs or so until the axillary one was placed. Dr said he doesn't know what is going on with it, and that he has never has this happen before. At this point, the balloon pump was completely failed, and was in v-tach a lot. He was pretty much unconscious. Dr had been on the phone with dr, who apparently told dr that wouldn't make it until morning if they took out and didn't replace it, so they needed to replace the pump. He was taken to the cath lab at about 3 am for a replacement maquet femoral balloon pump. I asked him what happened to the original pump. He indicated that he didn't see anything. He said that it was going to be sent back to the company for investigation and we would find out what happened. Tuesday 2019 and dr happened to walk by room. He stopped in, so i asked him what was happening with the faulty device. Dr said, he indicated that he did not see any oblivious defect when he took it out, but he called the company and they sent him a box to return the device in. He said he went back to the cath lab or wherever, the next day to retrieve the faulty device to send back and it was gone, someone has thrown it out. How does this happen? he also indicated that was not the only one this happened to (didn't he say before that he has never seen this happened?). He assured us that they has the original lot numbers and that "may be it was a bad batch of balloons", "don't worry, we used a different lot number on the one he has in. " it should also be known that while (b)(6) was in the icu waiting for a heart transplant, we became friendly with other's waiting. Between the 3 patients, there was a total eleven failed balloon pumps from the same company. " the iabp serial number is unknown at this time. Refer to related report on the intra-aortic balloon which was submitted under report #2248146-2019-00071.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key8488961
MDR Text Key141111305
Report Number2249723-2019-00551
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,consum
Reporter Occupation
Type of Report Initial
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-XX
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/05/2019 Patient Sequence Number: 1
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