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

Catalog Number IAP-0500

Device Problems Device Alarm System (1012); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call.A staff member from the cardiac cath lab called stating that he had a patient in the cardiac cath lab (ccl), and when they attempted to initiate pumping, they were getting "helium supply alarms." there was helium in the tank, the intra-aortic balloon (iab) was connected and there was not a trigger problem.They changed the console to a new one, and they were able to support the patient at expected.According to the caller all of the actions taken occurred prior to the hot line call.The caller told the clinical support specialist (css) that they had already completed the troubleshooting and console change out prior to reaching the css, and the console was sent to biomed for evaluation/repair.Length of time in use prior to the event: minutes.The patient was supported as expected.

Manufacturer Narrative

(b)(4).See also mdr #1219856-2017-00041.Teleflex received the device for analysis.The reported complaint of "alarm, purge failure" is confirmed.The field service engineer was able to duplicate the alarm during the repair.Dried blood and condensation were noted inside the vent valve v1 and drain valve v4 during the evaluation which is the root cause of the reported complaint.The cause of how the blood entered the pcs assembly is undetermined.A device history record (dhr) review was conducted for the serial and lot numbers with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex will continue to monitor for trends.

Event Description

It was reported via a hot line call.A staff member from the cardiac cath lab called stating that he had a patient in the cardiac cath lab (ccl), and when they attempted to initiate pumping, they were getting "helium supply alarms." there was helium in the tank, the intra-aortic balloon (iab) was connected and there was not a trigger problem.They changed the console to a new one, and they were able to support the patient at expected.According to the caller all of the actions taken occurred prior to the hot line call.The caller told the clinical support specialist (css) that they had already completed the troubleshooting and console change out prior to reaching the css, and the console was sent to biomed for evaluation/repair.Length of time in use prior to the event: minutes.The patient was supported as expected.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP
• 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: 6337243
• MDR Text Key: 67651687
• Report Number: 1219856-2017-00029
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

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
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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