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

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.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 9933040
• MDR Text Key: 186708175
• Report Number: 9933040
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2020
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1