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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Device Alarm System (1012); Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) gave a purge failure alarm.The team said they had everything connected properly and they could see the electrocardiogram (ecg) and arterial pressure (ap) waveform clearly.They did not know if the red heart was flashing.The rn stated the md decided to remove the intra-aortic balloon (iab) after the transport team arrived.There was no patient death or serious injury reported.
 
Manufacturer Narrative
(b)(4).For related complaint see mdr #3010532612-2018-00347 and (b)(4).Teleflex received the device for investigation.The reported complaint of "purge failure alarm" is not able to be confirmed.No abnormalities were noted with the returned driveline tubing and iab; the reported alarm could not be replicated during the investigation.Although, the root cause of the complaint has remained undetermined the returned device passed visual and functional test specifications.No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) gave a purge failure alarm.The team said they had everything connected properly and they could see the electrocardiogram (ecg) and arterial pressure (ap) waveform clearly.They did not know if the red heart was flashing.The rn stated the md decided to remove the intra-aortic balloon (iab) after the transport team arrived.There was no patient death or serious injury reported.
 
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Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8085420
MDR Text Key127622240
Report Number3010532612-2018-00341
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902007247
UDI-Public00801902007247
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17K0001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2018
Date Manufacturer Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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