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

Model Number IPN001112

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

There was no patient involvement.It was reported that during daily checks on the intra-aortic balloon pump (iabp), the user noticed that the ecg waveform during start-up was 'wonky' when there was no ecg connected.The iabp was also alarming 'fos out of range' and 'fos cal key missing or damaged'.For these reasons the user didn't used the iabp on patient and called to arrange a service visit, which was scheduled for monday 5th july.

Event Description

There was no patient involvement.It was reported that during daily checks on the intra-aortic balloon pump (iabp), the user noticed that the ecg waveform during start-up was 'wonky' when there was no ecg connected.The iabp was also alarming 'fos out of range' and 'fos cal key missing or damaged'.For these reasons the user didn't used the iabp on patient and called to arrange a service visit, which was scheduled for monday (b)(6).

Manufacturer Narrative

Qn#: (b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of several alarms is not able to be confirmed.The product was not returned for investigation.According to the service report, the fos pcb and fos slider were replaced.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 complaint.There are no new or revised risk.This will be monitored for any developing trends.

• 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: 12247777
• MDR Text Key: 264148682
• Report Number: 3010532612-2021-00211
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1