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

Catalog Number IAP-0500J

Device Problems Device Alarm System (1012); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "that the intra-aortic balloon pump (iabp) alarmed drain abnormality during use on a patient.Then the pump stopped temporarily.The iabp was still used on the patient and has continued to be used with a detached drain bottle.There was no report of patient death, serious injury or complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp drain failure alarm is not able to be confirmed.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 risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported "that the intra-aortic balloon pump (iabp) alarmed drain abnormality during use on a patient.Then the pump stopped temporarily.The iabp was still used on the patient and has continued to be used with a detached drain bottle.There was no report of patient death, serious injury or complications.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8179416
• MDR Text Key: 130894845
• Report Number: 3010532612-2018-00392
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902043429
• UDI-Public: 00801902043429
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1