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

Catalog Number IAP-0500J

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) had a drain failure during use on a patient.The staff drained the water but did not resolve the drain failure.As a result, the pump was swapped out.The distributor's technician retrieved the device from the hospital and tested the iabp using an iab simulator, the issue could not be duplicated.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of alarm drain failure is not able to be confirmed.Additional information from the distributor indicates the pump was serviced, and the service technician could not duplicate the reported alarm.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the intra-aortic balloon pump (iabp) had a drain failure during use on a patient.The staff drained the water but did not resolve the drain failure.As a result, the pump was swapped out.The distributor's technician retrieved the device from the hospital and tested the iabp using an iab simulator, the issue could not be duplicated.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8864228
• MDR Text Key: 156603243
• Report Number: 3010532612-2019-00249
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1