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

Model Number IPN001112

Device Problems Image Display Error/Artifact (1304); Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For complaint involving the same patient and event see mdr #3010532612-2020-00100 and (b)(4).

Event Description

It was reported by the registered nurse that the intra-aortic balloon (iab) catheter was inserted without difficulty, fiber optic arterial pressure (ap) waveform was present, zeroed, but the waveform was "not normal" and fiber optic messages including calibration key missing and corrupt continued to happen.The rn exchanged the intra-aortic balloon pump (iabp) but still had the same issues.As a result, a second iab catheter was inserted into the same insertion site.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#: (b)(4).No iap part was returned to teleflex chelmsford for investigation.The reported complaint of ap signal loss is confirmed based on the customer photo of the alarm history submitted in the complaint; however, a field service agent serviced the pump and could not be reproduce the issue.The pump passed functional checkout.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 revived risk.This will be monitored for any developing trends.Other remarks: for complaint involving the same patient and event see mdr #3010532612-2020-00100 and tc #: (b)(4).

Event Description

It was reported by the registered nurse that the intra-aortic balloon (iab) catheter was inserted without difficulty, fiber optic arterial pressure (ap) waveform was present, zeroed, but the waveform was "not normal" and fiber optic messages including calibration key missing and corrupt continued to happen.The rn exchanged the intra-aortic balloon pump (iabp) but still had the same issues.As a result, a second iab catheter was inserted into the same insertion site.There was no report of patient complications, serious injury or death.

• 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: 9953981
• MDR Text Key: 187560856
• Report Number: 3010532612-2020-00104
• 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: 03/24/2020

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 Model Number: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1