MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; INTRA-AORTIC BALLOON PUMP PRODUCTS

Catalog Number IAP-0500

Device Problems Pre Or Post-Pumping Problem (1477); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2014

Event Type  malfunction  

Event Description

It was reported that the event occurred while in the cardiac cath unit.When connecting the pressure interface cable to the pump, the bp showed 350 mmhg on the monitor.After changing the front end board (feb), the function was normal.There was no report of pt death, complications or injury.No medical/surgical intervention was required.Add'l info rec'd on (b)(4) 2014 stated that there was no delay or interruption in therapy.The pt outcome was no injury caused for the pt.The event occurred during pretest.The pump was switched out with the same default issue still unresolved.The pump is not back in service.It was noted that the arrow pump used in the event was an iap-0400, s/n (b)(4).An update rec'd on (b)(4) 2014 reported that the default issue should be the feb instead of the pump.The customer switched the pump off and restarted it again.The default issue still did not resolve.They did not use the iap-0400 until the feb was replaced.Info rec'd on (b)(4) 2014 reported that the second pump ran successfully while giving iabp therapy to the pt.

Manufacturer Narrative

(b)(4).

• Brand Name: AUTOCAT2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory associa ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3869079
• MDR Text Key: 21447338
• Report Number: 1219856-2014-00087
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2014
• Was Device Evaluated by Manufacturer?: No
• 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