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

Catalog Number IAP-0500

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: please refer to mdr #: 1219856-2017-00201 and (b)(4).

Event Description

It was reported that the event occurred in the cath lab.During use, there was a burning smell with the pump.As a result, the pump was removed and swapped out for another pump successfully.There was a delay or interruption in therapy that caused no harm.Medical/surgical intervention was not required.There was no reported death, serious injury or patient complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "burning smell coming from the pump" is not able to be confirmed.Although, the root cause of the reported complaint is undetermined the hospital biomed checked the pump and a burnt capacitor was found on the cpu board.The biomed replaced the cpu board and the pump was back in service.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.This issue will be monitored for any developing trends.Other remarks: please refer to mdr #: 1219856-2017-00201 and tc #: (b)(4).

Event Description

It was reported that the event occurred in the cath lab.During use, there was a burning smell with the pump.As a result, the pump was removed and swapped out for another pump successfully.There was a delay or interruption in therapy that caused no harm.Medical/surgical intervention was not required.There was no reported death, serious injury or patient complications.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6841904
• MDR Text Key: 84700964
• Report Number: 1219856-2017-00200
• Device Sequence Number: 1
• Product Code: DSP
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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