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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 Problem Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a field (b)(4). Symptom: patient coming off by-pass lost ap signal. Findings/action taken: found any time a static ap pressure on transducer line - would switch between monitor & transducer - in auto replaced 1/0 pcb - no longer switches between transducer & monitor with no or static transducer pressure - in auto performed functional checks and passed all. On 07/15/2016- additional information received: as a result of the ap signal lost the user swapped the pump off the patient. There was no harm to the patient.
 
Manufacturer Narrative
(b)(4) the i/o board (p/n 77-1100-001, (s/n (b)(4)) was returned for evaluation. Visual inspection of the i/o board was performed and no abnormalities were noted. The i/o board was installed into a known good autocat2w and the iabp was powered on. No static arterial pressure (ap) pressure on transducer line was noted while in auto mode. The intra-aortic balloon pump (iabp) was then left on for an hour in the initial power up condition to see if the reported complaint could be duplicated. During the half hour, the display head/iabp never switched states (between monitor and transducer). The iabp was then left to run for over 2 hours and no issues were noted (switch between monitor to transducer, and no static transducer pressure while in auto mode). 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. See other remarks section. Other remarks: conclusion: the reported complaint of "static transducer pressure and switch between monitor & transducer" was confirmed by the field service engineer; however, the reported problem could not be reproduced at teleflex (b)(4) during the functional test. The i/o board passed functional testing. The cause of the reported complaint is undetermined.
 
Event Description
It was reported via a field service report: (b)(4). Symptom: patient coming off by-pass lost ap signal. Findings/action taken: found any time a static ap pressure on transducer line - would switch between monitor & transducer - in auto replaced 1/0 pcb - no longer switches between transducer & monitor with no or static transducer pressure - in auto performed functional checks and passed all. On 07/15/2016- additional information received: as a result of the ap signal lost the user swapped the pump off the patient. There was no harm to the patient.
 
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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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5806303
MDR Text Key49913061
Report Number1219856-2016-00170
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 07/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Device Lot Number0001068978
Other Device ID Number30801902051715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2014
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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