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.

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.

Manufacturer Narrative

Qn#: (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of touchscreen error is not able to be confirmed.The touchscreen issue was resolved after the hospital staff rebooted the system.The root cause of the complaint is undetermined.If additional information or a part is received at a later date, the notification will be re-opened, and a full investigation will be completed.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.The reported complaint will be monitored for any developing trends.No further action required at this time.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9532615
• MDR Text Key: 184669758
• Report Number: 3010532612-2019-00459
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (y/n): N
• PMA/PMN Number: K162820
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Model Number: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1