MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/AJLA; SYSTREM INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0701

Device Problems Gas/Air Leak (2946); Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For event details on the same patient and event see mdr #3010532612-2019-00228 and (b)(4) also mdr #3010532612-2019-00229 and (b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) had stopped working due to lack of helium.The pump alarmed for helium loss 3 alarm, the helium bottle had to be replaced twice.The pump also alarmed for purge failure likely due to the empty helium tank or a connection issue.It was reported by the perfusionist that the patient was hemodynamically stable and therapy was discontinued as patient didn't require further iabp support.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).For event details on the same patient and event see mdr #3010532612-2019-00228 and tc #1900070393 also mdr #3010532612-2019-00229 and tc #1900070395.Teleflex did not receive the device for investigation.The reported complaint of iabp high rate consumption of helium is confirmed based on the pump recorder strips submitted with the complaint.Event details indicate the o-ring washer between the helium tank and helium adaptor was not in place, which can cause helium to leak from the helium tank.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.An in-service was generated to review positioning of the patient during iabp support, removal of the iab when a sheath is used, and proper procedure for replacement of helium bottles.

Event Description

It was reported that the intra-aortic balloon pump (iabp) had stopped working due to lack of helium.The pump alarmed for helium loss 3 alarm, the helium bottle had to be replaced twice.The pump also alarmed for purge failure likely due to the empty helium tank or a connection issue.It was reported by the perfusionist that the patient was hemodynamically stable and therapy was discontinued as patient didn't require further iabp support.There was no report of patient complications, serious injury or death.

• Brand Name: AC3 OPTIMUS IABP NA/AJLA
• Type of Device: SYSTREM INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8789248
• MDR Text Key: 150986629
• Report Number: 3010532612-2019-00240
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• 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: 06/21/2019

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-0701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 08/10/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTUBATED WITH INOTROPIC SUPPORT; INTUBATED WITH INOTROPIC SUPPORT; INTUBATED WITH INOTROPIC SUPPORT