MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN001112

Device Problems Erratic or Intermittent Display (1182); Failure to Calibrate (2440); Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the rn that the intra-aortic balloon pump (iabp) alarmed for purge failure and system error 7. The rn reported that the patient was transferred from an outside facility with a competitors iab. The clinical support specialist (css) walked the rn through the connections to the pump and therapy started. The rn reported that the screen "wasn't acting right". The css facetime with the staff, it was noted that the touchscreen needed a calibration when they attempted to pull up the arterial pressure (ap) window to zero. When the staff begin touchscreen calibration, a system error 7 was issued. The alarm was silenced by pressing the corner switch several times. Once the touchscreen calibration came up, the first target wouldn't respond. The css then had the staff power down and back up and the pump would restart therapy. The pump was swapped out. Pumping was interrupted for 1 minute. There was no report of patient injury or consequence. There were no complications, serious injury or death reported.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 9532615
• MDR Text Key: 184669758
• Report Number: 3010532612-2019-00459
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown