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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/AJLA SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/AJLA SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0701
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the intra-aortic balloon pump (iabp) was placed on a patient. After a while, the nurse observed that the "pump off" button was red and tried to turn it back "on". Both hard and soft keys were not responsive. The pump off timer is running. The "pump off" timer indicates 3 hours. The balloon is still pumping, evidence by the balloon waveforms responding to patient's electrocardiogram (ecg) and arterial pressure (ap). The pumping sound was present, and all patient's vital signs were fine. As a result, the pump was changed to an alternative source. It was reported that patient had no issues and was stable before and after the change in equipment. No adverse reactions were reported by the team in regard to the patient. There was no report of patient complications, serious injury or death.
 
Event Description
It was reported the intra-aortic balloon pump (iabp) was placed on a patient. After a while, the nurse observed that the "pump off" button was red and tried to turn it back "on". Both hard and soft keys were not responsive. The pump off timer is running. The "pump off" timer indicates 3 hours. The balloon is still pumping, evidence by the balloon waveforms responding to patient's electrocardiogram (ecg) and arterial pressure (ap). The pumping sound was present, and all patient's vital signs were fine. As a result, the pump was changed to an alternative source. It was reported that patient had no issues and was stable before and after the change in equipment. No adverse reactions were reported by the team in regard to the patient. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). No iabp parts was returned to teleflex chelmsford for investigation. The reported complaint of iabp pump status not displaying correctly is not able to be confirmed. The root cause of the complaint is undetermined. Additional information indicates that preventative maintenance was performed by the distributor's technician and no issues were noted. The pump is currently in service. 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. The reported complaint of iabp pump status not displaying correctly is not able to be confirmed. Teleflex assessed the risk for the reported complaint. There are no new or revived risk. This will be monitored for any developing trends.
 
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Brand NameAC3 OPTIMUS IABP NA/AJLA
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8640395
MDR Text Key146068333
Report Number3010532612-2019-00149
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,foreig
Type of Report Initial,Followup
Report Date 05/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0701
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No

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