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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number IPN000320
Device Problems Device Alarm System (1012); Break (1069); Device Sensing Problem (2917)
Patient Problem Arrhythmia (1721)
Event Date 02/25/2020
Event Type  malfunction  
Event Description
Intra aortic balloon pump inserted on [date redacted]. After balloon was placed in the descending aorta by the physician, the balloon pump was placed in 1:1 mode. It was noted that the pump was not consistently operating at a 1:1 ratio. We switched to 1:2 mode without an improvement in the triggering of the iabp. The usual trigger for iabp pump activation is the fiber optic signal, the fiber optic was not being sensed by the pump. The fiber optic light which is lit when functioning properly was not. The pump was using the transduced arterial blood pressure as its trigger but the pump was not consistently triggering at 1:1 rate as the blood pressure was labile. The pt was placed on the iabp ekg monitor. The patient was tachycardic (heart rate 120-130), the blood pressure was labile and the pump was giving an arrhythmia and a fos (fiber optic sensor) fail error message. A call was made to the company helpline, while waiting to speak to a company representative the decision was made to switch to a new pump. The new pump was set up and the iabp was placed on standby and switched. The new iabp was sensing the transduced blood pressure more consistently and we were getting a more consistent 1:1 augmenting of the pt blood pressure. I spoke with the company representative who asked me to look at the fiber optic sensor. From my visual description of the sensor the rep was able to conclude that the sensor was damaged. The pump would not be able to use the fiber optic trigger but we did have the ekg and transduced blood pressure to trigger from. The balloon pump catheter was repositioned for optimal placement and it was determined that the transduced arterial pressure and the pt ekg were adequate triggers and the patient was being augmented at a 1: 1 ratio consistently. No harm came to the patient during this time. Pt was transferred to icu.
 
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Brand NameARROW
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
2400 bernville road
reading PA 19605
MDR Report Key9933040
MDR Text Key186708175
Report Number9933040
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000320
Device Catalogue NumberIAP-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/23/2020
Device Age14 YR
Event Location Hospital
Date Report to Manufacturer04/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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