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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); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a field service report (b)(4). Symptom: purge failure alarms occurred on patient (op). Findings/action taken: replaced the pcs assy. Software level 2. 24, fcn level: 1416 per the hospital biomed, the pump was switched out without issues.
 
Manufacturer Narrative
(b)(4). See mdr #1219856-2017-00029. Complaint (b)(4) was opened erroneously. All information is contained in the initial complaint (b)(4).
 
Event Description
It was reported via a field service report (b)(4). Symptom: purge failure alarms occurred on patient (op). Findings/action taken: replaced the pcs assy. Software level 2. 24, fcn level: 1416. Per the hospital biomed, the pump was switched out without issues. 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 Key6350247
MDR Text Key68086259
Report Number1219856-2017-00041
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number30801902051715
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? No
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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