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

Catalog Number	IAP-0500I
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that when the intra-aortic balloon pump (iabp) was in use, the pump alarmed for "low helium".The staff noted that they were having a leaking problem, which lead them to use 2 helium canisters for a 24-hour therapy.There was no reported problem with therapy delivery.As a result, the helium canister was replaced to the end of therapy.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
Event or Problem Description
It was reported that when the intra-aortic balloon pump (iabp) was in use, the pump alarmed for "low helium".The staff noted that they were having a leaking problem, which lead them to use 2 helium canisters for a 24-hour therapy.There was no reported problem with therapy delivery.As a result, the helium canister was replaced to the end of therapy.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "helium leakage" is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial 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 or Problem Description
It was reported that when the intra-aortic balloon pump (iabp) was in use, the pump alarmed for "low helium".The staff noted that they were having a leaking problem, which lead them to use 2 helium canisters for a 24-hour therapy.There was no reported problem with therapy delivery.As a result, the helium canister was replaced to the end of therapy.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "helium leakage" is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial 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.Other remarks: the complaint was reopened to investigate the device that was returned for investigation.The report complaint of "leak in helium supply" is not confirmed.The returned helium regulator assembly passed functional test specifications during complaint investigation.The root cause of the complaint is undetermined.No further action required at this time.

• Brand Name: AUTOCAT2 WAVE ITALIAN
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8473203
• Report Number: 3010532612-2019-00089
• Device Sequence Number: 16522735
• Product Code: DSP
• UDI-Device Identifier: 00801902092199
• UDI-Public: 00801902092199
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAP-0500I
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/30/2019; 06/14/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 05/01/2019; 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1