Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Consequences Or Impact To Patient (2199)
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
Qn#(b)(4).Teleflex did not receive the device for investigation.The reported complaint of iabp red x's on helium and battery icons and erratic ap and ecg waveforms is confirmed based on the video submitted with the complaint.The root cause of this complaint is undetermined.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 to further investigate 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.
 
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 received the device for investigation.The reported complaint of iabp red x's on helium and battery icons and erratic ap and ecg waveforms is confirmed based on the video submitted with the complaint; however, the returned cpm board passed visual and functional test specifications during complaint investigation.The root cause of the complaint is undetermined.A non-conformance for "no ecg trace, unable to set date/time.", "constant piezo alarm and blank display.", "constant piezo alarm", " capacitor c159 has fallen off cpm pcb.", "no display and valve leds not working.", "no assisted ap waveform.", "c810 on cpm has polarities reversed.", "powers up with piezo alarm/no display." for part number 33-1000-003 are relevant.The parts affected by these no nconformances were returned to the vendor.The remainder of the lot was released per procedure.No nonconformances were documented on the pump's finished kit (p/n: iap-0700) or semi-finished kit (p/n: 33-3000-001).The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.Corrected data: the "device available for evaluation" field was updated from "no" to "yes" as the sample was returned for investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AC3 OPTIMUS IABP NA/EMEA
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9087974
MDR Text Key182362824
Report Number3010532612-2019-00361
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
1 Patient was 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 Health Professional
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2020
Date Manufacturer Received05/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-