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

Catalog Number IAP-0500J

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the intra-aortic balloon pump (iabp) was in use, the staff experienced an alarm stating, "possibility of foreign substance in helium line".As a result, the pump was swapped out for another.Patient outcome reported as fine.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp alarm: helium loss is not confirmed.A certified service technician serviced the pump and could not replicate the issue.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 complaints.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 that when the intra-aortic balloon pump (iabp) was in use, the staff experienced an alarm stating, "possibility of foreign substance in helium line".As a result, the pump was swapped out for another.Patient outcome reported as fine.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8320586
• MDR Text Key: 135532904
• Report Number: 3010532612-2019-00021
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902043429
• UDI-Public: 00801902043429
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• 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?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1