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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 Erratic or Intermittent Display (1182); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the field engineer that on the intra-aortic balloon pump (iabp) a weird display screen appears. The electrocardiogram (ecg) and pressure freezes, and gas icon and battery icon go to red x. As a result, the cpm board was replaced. There was no reported patient injury or consequence.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of waveforms frozen with red x on helium and battery icon was confirmed by the field service technician. As a result, the field service replaced the cpm board. The root cause of the complaint is undetermined. If the part is received at a later date, the notification will be reopened, and a full investigation will be completed. 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. No further action required at this time. Other remarks: this complaint was reopened to investigate the device that was returned to teleflex for investigation. The reported complaint of waveforms frozen with red x's on the helium and battery icon was confirmed by the field service technician. However, the symptoms could not be duplicated during the complaint investigation of the returned cpm board. The root cause of the complaint is undetermined. 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. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. This will be monitored for any developing trends. A corrective and preventive action request has been initiated for the issue.
 
Event Description
It was reported by the field engineer that on the intra-aortic balloon pump (iabp) a weird display screen appears. The electrocardiogram (ecg) and pressure freezes, and gas icon and battery icon go to red x. As a result, the cpm board was replaced. There was no reported patient injury or consequence.
 
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Brand NameAC3 OPTIMUS IABP NA/EMEA
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9087964
MDR Text Key159317052
Report Number3010532612-2019-00360
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902084965
UDI-Public00801902084965
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,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Is This a Reprocessed and Reused Single-Use Device? No

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