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

Catalog Number IAP-0500

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the nurse that the helium tank on the intra-aortic balloon pump (iabp) had to be changed twice, but the helium gauge still reads red.The rn reported it had been fine through the night and the pump has continued to pump with no interruptions or issues.The clinical support specialist (css) had the nurse attempt another tank with the same result.The nurse then got another pump, turn it on and the helium tank registered blue, almost full.The nurse took the tank from that pump and put it on the current pump and the tank registered red, almost empty.As a result, the pump was exchange without difficulty and will be sent to biomed.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp helium tank displaying empty is not confirmed.A teleflex field service engineer serviced the pump and could not duplicate the reported complaint.The pump passed functional checkout.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.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported by the nurse that the helium tank on the intra-aortic balloon pump (iabp) had to be changed twice, but the helium gauge still reads red.The rn reported it had been fine through the night and the pump has continued to pump with no interruptions or issues.The clinical support specialist (css) had the nurse attempt another tank with the same result.The nurse then got another pump, turn it on and the helium tank registered blue, almost full.The nurse took the tank from that pump and put it on the current pump and the tank registered red, almost empty.As a result, the pump was exchange without difficulty and will be sent to biomed.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: 9459605
• MDR Text Key: 183767443
• Report Number: 3010532612-2019-00441
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.