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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
Model Number IPN001112
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).Teleflex reassessed the information contained in this complaint and determined that it should have been submitted to fda as a 30-day report in accordance with 21 cfr part 803.This report is being submitted as a combined initial 30-day and follow up to include our investigation findings.Teleflex investigation findings: teleflex received the device for investigation.The reported complaint of the motor driver connector and cable connector burnt is confirmed.Upon return, a burn mark/melted connector cable was noted on the motor driver connector and on the motor driver cable.The returned device was too damaged to analyze.A capa investigation; determined the root cause of the burnt connectors is a combination of the molex connector on the motor driver pcb and the motor driver cable.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.
 
Event Description
It was reported by the field service engineer (fse) that the intra-aortic balloon pump (iabp) gave the error 3 pump/controller failure prior to use on a patient during inspection/functional testing.As a result, the customer used another functioning iabp.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn#: (b(4).Teleflex reassessed the information contained in this complaint and determined that it should have been submitted to fda as a 30-day report in accordance with 21 cfr part 803.This report is being submitted as a combined initial 30-day and follow up to include our investigation findings.Teleflex investigation findings: teleflex received the device for investigation.The reported complaint of the motor driver connector and cable connector burnt is confirmed.Upon return, a burn mark/melted connector cable was noted on the motor driver connector and on the motor driver cable.The returned device was too damaged to analyze.A capa investigation; determined the root cause of the burnt connectors is a combination of the molex connector on the motor driver pcb and the motor driver cable.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.
 
Event Description
It was reported by the field service engineer (fse) that the intra-aortic balloon pump (iabp) gave the error 3 pump/controller failure prior to use on a patient during inspection/functional testing.As a result, the customer used another functioning iabp.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 Key11962001
MDR Text Key261006752
Report Number3010532612-2021-00176
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902084966
UDI-Public30801902084966
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,foreig
Type of Report Initial,Followup
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN001112
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Date Manufacturer Received01/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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