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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0700
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had the intra-aortic balloon (iab) placed when the patient was in the cath lab.The patient went to the or and when returned to the icu the nurse stated that the intra-aortic balloon pump (iabp) alarmed "purge failure" and would not restart when they reset the alarm and tried to pump.As a result the pump was switched for a second iabp.The patient continued to be supported on the second iabp.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4) related complaint on the same patient and event see mdr #3010532612-2019-00174 and (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp purge failure alarm is not able to be confirmed.A teleflex field service engineer serviced the pump and could not duplicate the reported alarm.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported that the patient had the intra-aortic balloon (iab) placed when the patient was in the cath lab.The patient went to the or and when returned to the icu the nurse stated that the intra-aortic balloon pump (iabp) alarmed "purge failure" and would not restart when they reset the alarm and tried to pump.As a result the pump was switched for a second iabp.The patient continued to be supported on the second iabp.There was no report of patient complications, serious injury or death.
 
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Brand Name
AC3 OPTIMUS IABP NA/EMEA
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8622372
MDR Text Key145491010
Report Number3010532612-2019-00140
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
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