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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2 INTRA-AORTIC BALLOON PUMP

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ARROW INTERNATIONAL INC. AUTOCAT 2 INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0400
Device Problem Device Alarm System (1012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was been reported that the event involved a male patient. While in the catheter room the intra-aortic balloon (iab) was prepped and inserted via the patient's left femoral artery. The patient received intra-aortic balloon pump (iabp) therapy for 30 minutes when the pump alarmed "high baseline". The alarm was shut down however it occurred again. The md exchanged the pump to continue the intra-aortic balloon pump (iabp) therapy. There was a one minute delay in intra-aortic balloon pump (iabp) therapy. There was no reported patient death, injury or complications. Medical / surgical intervention was not required. The patient outcome is listed as "well". The engineer took the pump to the office and inspected the pump and found abnormal sound. The "stepped monitor" (b)(4) malfunction was confirmed.
 
Manufacturer Narrative
Qn#(b)(4). The pump assembly (p/n: 77-3200-001w) was returned without its original pcs assembly. Visual inspection of pump assembly was performed and no abnormalities were noted. A know good pcs assembly was installed onto the pump assembly in question. The pump assembly in question was then installed into a known good autocat2w and functional testing was performed. Excessive noise was noted from the pump assembly and the pump alarmed high baseline 1 approximately 6 seconds after pumping was initiated. A visual inspection of the pump assembly internal hardware was performed and no abnormalities were noted. The stepping motor was replaced with a known good one and the functional test was performed. The pump was pumping smoothly with no excessive noise. The pump passed both balloon volumes and helium leak tests. The pump was then left to run for over 2 hours and no alarms or errors were occurred. Other remarks: a device history record (dhr) review was conducted for the iabp serial/ lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported problem of "alarm, high baseline" is confirmed. The pump alarmed high baseline 1 approximately 6 seconds a fter initiating pumping and excessive noise was noted. The pump passed functional testing after the stepping motor was replaced. The reported complaint was caused by the stepping motor; however, the cause of the stepping motor malfunction is undetermined. Engineering was notified, this type of issue will be monitored for any developing trend.
 
Event Description
It was been reported that the event involved a male patient. While in the catheter room the intra-aortic balloon(iab)was prepped and inserted via the patients left femoral artery. The patient received intra-aortic balloon pump(iabp)therapy for 30 minutes when the pump alarmed "high baseline". The alarm was shut down however it occurred again. The md exchanged the pump to continue the intra-aortic balloon pump (iabp) therapy. There was a one minute delay in intra-aortic balloon pump (iabp) therapy. There was no reported patient death, injury or complications. Medical / surgical intervention was not required. The patient outcome is listed as "well". The engineer took the pump to the office and inspected the pump and found abnormal sound. The "stepped monitor" (ar-77-3200-001w) malfunction was confirmed.
 
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Brand NameAUTOCAT 2
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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6110684
MDR Text Key60285088
Report Number1219856-2016-00254
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0400
Other Device ID Number30801902051722
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2016
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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