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

Catalog Number IAP-0500

Device Problems Device Alarm System (1012); Mechanical Problem (1384); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the registered nurse (rn) that an alarm was encountered while the intra-aortic balloon pump (iabp) was in use.The rn stated that the pump had alarm several times for a "valve control failure".The rn also stated that when the pump alarmed "valve control failure", the pump would stop pumping.As a result, the clinical walked the staff through switching out the pump.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "system error 3 alarm" is not able to be c onfirmed.It was reported by the field service engineer that due to the high cost of repair the pump was removed from service.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.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported by the registered nurse (rn) that an alarm was encountered while the intra-aortic balloon pump (iabp) was in use.The rn stated that the pump had alarm several times for a "valve control failure".The rn also stated that when the pump alarmed "valve control failure", the pump would stop pumping.As a result, the clinical walked the staff through switching out the pump.There was no report of patient complication or serious injury and death.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7776695
• MDR Text Key: 116894332
• Report Number: 3010532612-2018-00254
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902051714
• UDI-Public: 00801902051714
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1