MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0500

Device Problem No Display/Image (1183)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

The report states "display went blank during transport".Additional information received states that "the device was used on a patient and when the patient was transported to the ambulance, the screen went black".As a result, the pump was exchanged with another pump.No patient harm or injury.

Manufacturer Narrative

Qn# (b)(4).The reported complaint of "display went blank" was confirmed upon investigation of the returned sample.The customer returned an autocat2 series display cable assembly (p/n: 96-3701-001) for investigation.The sample was returned in a white cardboard box, protected by protective shipping packaging (inp-1, inp-2).Visual inspection of the display cable was performed (inp-2 through inp-7), and no abnormality was noted.The continuity check of the display cable assembly was performed and no connection was present.Visual inspection of the display cable assembly internal hardware was performed by removing the cable connector housing, and the cables were noted separated from the connector (anp-1 through anp-3).Based on a review of the device history record (dhr), the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the damaged cable.The root cause of the complaint is undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a; corrected data: n/a.

Event Description

The report states "display went blank during transport." additional information received states that "the device was used on a patient and when the patient was transported to the ambulance, the screen went black".As a result, the pump was exchanged with another pump.No patient harm or injury.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18209151
• MDR Text Key: 329003703
• Report Number: 3010532612-2023-00698
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.