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

Catalog Number IAP-0500

Device Problems Device Alarm System (1012); No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported by the registered nurse (rn) that the intra-aortic balloon pump (iabp) has been pumping fine on the patient, but all the waveforms on the pump went "flatline".The staff tried changing out the ecg leads and checked all connections with no changes.As a result, the pump was switched out for another, and all waveforms are present.Patient's condition reported as fine.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 ecg waveform missing is not able to be confirmed.The pump was serviced by a certified hospital biomed.Of note, the front end board and internal ecg cable were replaced.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot 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 by the registered nurse (rn) that the intra-aortic balloon pump (iabp) has been pumping fine on the patient, but all the waveforms on the pump went "flatline".The staff tried changing out the ecg leads and checked all connections with no changes.As a result, the pump was switched out for another, and all waveforms are present.Patient's condition reported as fine.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: 8170726
• MDR Text Key: 130621711
• Report Number: 3010532612-2018-00378
• 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: 11/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• 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
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1