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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.
 
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Brand NameAC3 OPTIMUS IABP NA/EMEA
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
kaylia pen
2400 bernville road
reading, PA 19605
MDR Report Key11962001
MDR Text Key261006752
Report Number3010532612-2021-00176
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/28/2019
1 Device was Involved in the Event
0 Patients were 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
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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