MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN001112

Device Problem Failure to Calibrate (2440)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the staff was getting cal key missing/corrupt messages.There was a waveform but no pressure readings.The intr a-aortic balloon (iab) was zeroed prior to insertion.As a result, the intra-aortic balloon pump (iabp) was swapped out.The iabp will be sent to biomed to be checked.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the staff was getting cal key missing/corrupt messages.There was a waveform but no pressure readings.The intr a-aortic balloon (iab) was zeroed prior to insertion.As a result, the intra-aortic balloon pump (iabp) was swapped out.The iabp will be sent to biomed to be checked.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of cal key missing/corrupt messages is not able to be confirmed.According to the field service database, no service has been performed on this pump as of (b)(6) 2021.If the part or additional information is received at a later day, a full investigation will be completed.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: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12120604
• MDR Text Key: 260293418
• Report Number: 3010532612-2021-00177
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• 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?: Yes
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1