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

Model Number IPN000320

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.

Event Description

It was reported by the clinical support specialist (css) that the pump had persistent drain failure alarms.There was no condensation/water building up in the gas tubing, and the drain bottle only had a minimal amount of condensation.The staff tried a manual purge; however, the alarms persisted.As a result, the pump was exchanged for a different pump.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of drain failure alarm is not able to be confirmed.The field service engineer (fse) checked the pump and could not replicate the issue.If the part is returned at a later date, a full investigation will be performed.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 revised risk.This will be monitored for any developing trends.

Event Description

It was reported by the clinical support specialist (css) that the pump had persistent drain failure alarms.There was no condensation/water building up in the gas tubing, and the drain bottle only had a minimal amount of condensation.The staff tried a manual purge; however, the alarms persisted.As a result, the pump was exchanged for a different pump.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Returned for investigation was an autocat2 pcs assembly.The sample was returned in a brown cardboard box with protective shipping packaging.Visual inspection of the pcs assembly was performed.No abnormality was noted.All valves were individually tested by powering them on and off using an external power supply, and all valves functioned as intended.The pcs assembly was installed into a known good lab inventory ac2 for functional testing.The pump was powered on, and pumping was initiated.The purge cycle was performed multiple times with no alarms or errors were occurred.The leak test was performed and passed both source side and patient side.The pump was then left to run for over 90 minutes and no alarms or errors occurred.Visual inspection of the pcs assembly internal hardware was performed, and no abnormality was noted.The reported complaint of "drain failure alarm" is not confirmed.The returned pcs assembly passed visual and functional test specifications during the complaint investigation.A device history record review was performed, and no relevant findings were identified.The root cause of the complaint is undetermined.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported by the clinical support specialist (css) that the pump had persistent drain failure alarms.There was no condensation/water building up in the gas tubing, and the drain bottle only had a minimal amount of condensation.The staff tried a manual purge; however, the alarms persisted.As a result, the pump was exchanged for a different pump.There was no report of patient complications, serious injury or death.

• 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: marling heaton ; 3015 carrington mill blvd; morrisville, MA 27560
• MDR Report Key: 14316061
• MDR Text Key: 291475098
• Report Number: 3010532612-2022-00155
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000320
• 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?: Yes
• Date Manufacturer Received: 11/04/2022
• 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
• Patient Sex: Male