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

Catalog Number IAP-0500

Device Problems Deformation Due to Compressive Stress (2889); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the rn that they have a patient on the intra-aortic balloon pump (iabp) and the pump had a low helium tank alarm and they changed out the helium tank.Then the pump alarmed again, and the pump stopped pumping.The rn reported unable to refill, high baseline and possible helium loss.There is no signs of blood in the tubing.The patient is a fairly large patient so they had to put traction on the catheter and hyperextend the hip.The pump pumped for several minutes and then it alarmed again.As a result, the pump was switched out for a second pump without consequence.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp multiple alarms: "unable to refill", "high baseline", and "possible helium loss" is not able to be confirmed.An elevated baseline was noted on the recorder strip and pump display photos submitted with the complaint, however, no alarms were noted on the photos provided.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 revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported by the rn that they have a patient on the intra-aortic balloon pump (iabp) and the pump had a low helium tank alarm and they changed out the helium tank.Then the pump alarmed again, and the pump stopped pumping.The rn reported unable to refill, high baseline and possible helium loss.There is no signs of blood in the tubing.The patient is a fairly large patient so they had to put traction on the catheter and hyperextend the hip.The pump pumped for several minutes and then it alarmed again.As a result, the pump was switched out for a second pump without consequence.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8780414
• MDR Text Key: 150698972
• Report Number: 3010532612-2019-00213
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DOBUMATAMINEAMIODARONE; DOBUMATAMINEAMIODARONE; DOBUMATAMINEAMIODARONE
• Patient Weight: 136