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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 Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) display head does not stay in place and flops over.As a result, the iabp was switched out quickly.There was no report of patient complication or serious injury and death.The pump was sent to biomed to be service.It was found that the slotted spring pin was missing.The pin was sent to and replaced by the biomed.
 
Manufacturer Narrative
(b)(4).No iabp parts was returned to teleflex chelmsford for investigation.The reported complaint of iabp "display head does not stay in place" is confirmed by a teleflex field service engineer, however, no part was returned to teleflex chelmsford for investigation.A slotted spring pin on the display head was noted missing and was replaced by the hospital biomed.The root cause of this 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 revived risk.This will be monitored for any developing trends.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) display head does not stay in place and flops over.As a result, the iabp was switched out quickly.There was no report of patient complication or serious injury and death.The pump was sent to biomed to be service.It was found that the slotted spring pin was missing.The pin was sent to and replaced by the biomed.
 
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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 Key8782150
MDR Text Key150819811
Report Number3010532612-2019-00236
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 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
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 Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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