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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 Low Blood Pressure/ Hypotension (1914)
Event Date 06/26/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).For complaint related to the same patient and event see mdr #3010532612-2019-00219 and tc # (b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) pump shut off suddenly, unknown cause.The machine cycled power out and the pump did not start fast enough and then received a purge failure alarm.As a result, the pump was swapped out.The rn reported that the patient's bp dropped transiently when this occurred.The field service engineer could not reproduce symptom.There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) pump shut off suddenly, unknown cause.The machine cycled power out and the pump did not start fast enough and then received a purge failure alarm.As a result, the pump was swapped out.The rn reported that the patient's bp dropped transiently when this occurred.The field service engineer could not reproduce symptom.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4) for complaint related to the same patient and event see mdr #3010532612-2019-00219 and tc #(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "purge failure alarm" is not able to be confirmed.The field service engineer checked the pump and could not replicate the problem.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial 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 risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
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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 Key8807095
MDR Text Key151581151
Report Number3010532612-2019-00253
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 06/26/2019
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 Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/26/2019
Initial Date FDA Received07/19/2019
Supplement Dates Manufacturer Received08/15/2019
Supplement Dates FDA Received08/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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