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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 Problems Signal Artifact/Noise (1036); Image Display Error/Artifact (1304); Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/26/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) compared to the wall monitor was triple counting the r wave before patient prepping, for example, wall monitor reads 60, iabp reads 170, and balloon inflated/deflated accordingly (at that time, patient electrocardiogram leads had all been removed and the console was slaved off the wall monitor).The perfusionist plug and unplug the slave cable, unable to solve the problem; then switched from 1:1 to 1:2, still working at 1:1.The perfusionist swapped out the console.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation.The reported complaint of the triggered ap was able to be confirmed by the customer photo.The field service engineer serviced the pump and could not confirm the triggering difficulty.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 risks.The reported complaint will be monitored for any developing trends.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) compared to the wall monitor was triple counting the r wave before patient prepping, for example, wall monitor reads 60, iabp reads 170, and balloon inflated/deflated accordingly (at that time, patient electrocardiogram leads had all been removed and the console was slaved off the wall monitor).The perfusionist plug and unplug the slave cable, unable to solve the problem; then switched from 1:1 to 1:2, still working at 1:1.The perfusionist swapped out the console.There was a report of delay in therapy.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 Key8899177
MDR Text Key154551855
Report Number3010532612-2019-00272
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 07/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2019
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 Received09/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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