MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; IABP AUTOCAT 2 WAVE PUMP CONSOLE

Catalog Number IAP-0500

Device Problem Gas/Air Leak (2946)

Patient Problem Congestive Heart Failure (1783)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

It was reported that in the catheter room the iab was inserted via a sheath in the patients left femoral artery.The doctor stated, that one bottle of helium was finished in one day and the consumption was too fast.The pump was exchanged off the patient.There was no reported patient death, injury or complications.Medical/surgical intervention was not required.The length of time prior to this event was 6 hours.The pump was sent to be looked at.The engineer decided to return this machine to company for detailed inspections.He connected alternating current to iabp machine.The machine showed helium pressure was 422psi.Then he turned down the helium adaptor knob, the pressure was decreased slowly.It was indicated that the machine had an internal leak.The engineer inspected reducing valve and tested again, at this time, the pressure was 420psi.When he clamped valve pipeline and turned down the knob the pressure was still decreased.The reducing valve had internal leak.He replaced it with a new reducing valve and leakage was not found.

Manufacturer Narrative

Qn#(b)(4).

• Brand Name: AUTOCAT2 WAVE
• Type of Device: IABP AUTOCAT 2 WAVE PUMP CONSOLE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger, clinical spe ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 4665193
• MDR Text Key: 5728432
• Report Number: 1219856-2015-00079
• 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: Other
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 74