MAUDE Adverse Event Report: ARROW INTL., INC. AUTOCAT2 WAVE JAPANESE; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0500J

Device Problems No Audible Alarm (1019); Pumping Stopped (1503)

Patient Problem Myocardial Infarction (1969)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

It was reported that the event involved a (b)(6) female patient, height (b)(6), weight (b)(6) while in the patient's room during use.The patient's bad condition was confirmed before inserting the intra-aortic balloon (iab) via left femoral artery without issue on (b)(6) 2014 at 2:00 am.The nurse noticed the intra-aortic balloon pump's (autocat2 wave) suspension as it made no sound in the early morning of (b)(6) 2014.The pumping had stopped and the monitor's wave had become flat.The user rebooted in autopilot mode, but due to the electrocardiogram noise switched into ap mode automatically and stopped again.The user then rebooted manually with the ecg trigger.During this event, there was no alarm confirmed at all; pumping stopped without alarming.Pump strips are available for review.There was no report of patient death, complications or injury.No medical/surgical intervention was required.The patient outcome is good.Additional information received on (b)(4) 2014 stated that the pump was not removed nor replaced.They couldn't tell how long the pump had stopped, but it caused no harm to the patient.They were able to finish iabp therapy successfully.The pump strips that were generated will be sent.It was noted that the pump will be investigated at (b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, ra ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4102045
• MDR Text Key: 4713598
• Report Number: 1219856-2014-00168
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 80