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

Model Number IPN000334

Device Problems Mechanical Problem (1384); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the intra-aortic balloon pump (iabp) was in use on a patient, a system error 3 alarm occurred.As a result, the iabp was swapped out.There was no report of patient complications, serious injury or death.

Event Description

It was reported that when the intra-aortic balloon pump (iabp) was in use on a patient, a system error 3 alarm occurred.As a result, the iabp was swapped out.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No iap part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of system error 3 alarm is not able to be confirmed.If any part or further information is received at a later date, an investigation will be performed.Follow up information indicated that the distributor had submitted a repair estimate; however, no further information has been received.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.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9986039
• MDR Text Key: 188536994
• Report Number: 3010532612-2020-00109
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902091780
• UDI-Public: 30801902091780
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000334
• Device Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.; NI.