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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500
Device Problems Unable to Obtain Readings (1516); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2017
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of "fos not recognized" is not able to be confirmed. The pump was checked by the hospital biomed and the problem could not be reproduced. The root cause of the reported complaint is undetermined. 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. This complaint will be monitored for any developing trends.
 
Event Description
It was reported that the rn called the clinical support specialist to troubleshoot a "light weight sensor (lws)". The fiber optic sensor (fos) waveform has been a flat line during all of the troubleshooting attempts. The rn was not able to switch the pump at the time of the call and therefore the central lumen was flushed and utilized. The waveform is much better and the patient support looks "great. A second call was received the following day with the same patient and same pump. The second rn called to troubleshoot "low augmentation". The css discussed with the rn the multiple factors with augmentation. During discussion, the css suggested connecting the fos to another console. The rn was able to connect the fos to a second pump. The rn received a waveform as expected and they were able to calibrate the fiber optic sensor and the icon is white. The patient continued to receive therapy. There was no reported death or complications to the patient. A delay in therapy while exchanging the pump but no harm to the patient was caused. Patient outcome: the patient remained stable.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the rn called the clinical support specialist to troubleshoot a "light weight sensor (lws)". The fiber optic sensor (fos) waveform has been a flat line during all of the troubleshooting attempts. The rn was not able to switch the pump at the time of the call and therefore the central lumen was flushed and utilized. The waveform is much better and the patient support looks "great. A second call was received the following day with the same patient and same pump. The second rn called to troubleshoot "low augmentation". The css discussed with the rn the multiple factors with augmentation. During discussion, the css suggested connecting the fos to another console. The rn was able to connect the fos to a second pump. The rn received a waveform as expected and they were able to calibrate the fiber optic sensor and the icon is white. The patient continued to receive therapy. There was no reported death or complications to the patient. A delay in therapy while exchanging the pump but no harm to the patient was caused. Patient outcome: the patient remained stable.
 
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Brand NameAUTOCAT2 WAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
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 Key6731849
MDR Text Key248231266
Report Number1219856-2017-00155
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 06/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2017
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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