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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 Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) had a system error 7 alarm during use on a patient.As a result, the pump was swapped out.The field service engineer (fse) was called in to service the pump.During service, it was found that the corner switch was stuck in the down position.The fse replaced the display as a result.There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iabp system error 7 alarm is confirmed.A misaligned corner switch release spring was noted during the complaint investigation, which can cause the corner switch to remain engaged and result in a system error 7 alarm.The root cause of the complaint is undetermined.A potential cause is user interaction with the corner switch causing the spring to disengage.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.This will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) had a system error 7 alarm during use on a patient.As a result, the pump was swapped out.The field service engineer (fse) was called in to service the pump.During service, it was found that the corner switch was stuck in the down position.The fse replaced the display as a result.There was no report of patient complication or serious injury and 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 Key8924915
MDR Text Key155382787
Report Number3010532612-2019-00288
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
Type of Report Initial,Followup
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2019
Date Manufacturer Received09/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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