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

Catalog Number IAP-0500D

Device Problems Display or Visual Feedback Problem (1184); Pre Or Post-Pumping Problem (1477); Failure to Zero (1683)

Patient Problem Cardiogenic Shock (2262)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

It was reported that the event occurred while in the cath lab prior to insertion.During product prep the fiberoptix sensor (fos) intra-aortic balloon (iab) was connected to the intra-aortic balloon pump (iabp) and was not detected.The cal key was also connected and detected, but the blue sensor was not.No automatic or manual zeroing was possible.The device was not used.They opened another iab kit and the same issue occurred.As a result, the pt was related conventionally with medication to stabilize the circulatory system.They did not use the iab as a fluid filled catheter since they did not have any transducer cables on the pump.The sales rep discussed this with the customer and they have since placed an order after this event.They did without iabp therapy because they didn't trust the pump and they only have one pump at this facility.There was no report of pt death, complications or injury.There was an indefinite delay or interruption in therapy with no harm to the pt noted.The pt outcome is okay.The pump will be checked by a third party service organisation.The sales rep checked the pump with the tester and it worked, but the customer wants a check from our technical service.Additional info received from the sales rep stated that the facility has only one iabp.

Manufacturer Narrative

(b)(4).Device will not be returned for eval.

• Brand Name: AUTOCAT2 WAVE GERMAN
• Type of Device: INTRA-AORTIC BALLOON PUMP PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, reg associate ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 3837728
• MDR Text Key: 19801111
• Report Number: 1219856-2014-00057
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2014
• 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