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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
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.
 
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Brand NameAUTOCAT2 WAVE
Type of DeviceINTRA-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 Key6337243
MDR Text Key67651687
Report Number1219856-2017-00029
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number00801902051714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2017
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 Unkown

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