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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Failure to Zero (1683); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint that the fos would not zero is not able to be confirmed. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint will be monitored for developing trends. If the sample is returned at a later date, an investigation of the product will be completed.
 
Event Description
It was reported that the rn has tried to zero the intra-aortic balloon (iab) on four different pumps without success. Therefore, a second iab was opened and the fiber optic sensor (fos) was also not recognized. They were able to manually calibrate the second iab after insertion and it is working well. Patient outcome: meeting goals of therapy. There was a reported delay and interruption in therapy but no harm caused to the patient. There were no patient complication, death or serious injury reported. There was no medical/surgical intervention required.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint that the fos would not zero is not able to be confirmed. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint will be monitored for developing trends. If the sample is returned at a later date, an investigation of the product will be completed. Teleflex received the device for investigation therefore the complaint was reopened. The reported complaint of fos would not zero is confirmed. The fiber was found broken; therefore, a light path could not be established between the sensor and the pump. The root cause of the broken fiber 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. A nonconformance has been initiated to further investigate the root cause.
 
Event Description
It was reported that the rn has tried to zero the intra-aortic balloon (iab) on four different pumps without success. Therefore, a second iab was opened and the fiber optic sensor (fos) was also not recognized. They were able to manually calibrate the second iab after insertion and it is working well. Patient outcome: meeting goals of therapy. There was a reported delay and interruption in therapy but no harm caused to the patient. There were no patient complication, death or serious injury reported. There was no medical/surgical intervention required.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the rn has tried to zero the intra-aortic balloon (iab) on four different pumps without success. Therefore, a second iab was opened and the fiber optic sensor (fos) was also not recognized. They were able to manually calibrate the second iab after insertion and it is working well. Patient outcome: meeting goals of therapy. There was a reported delay and interruption in therapy but no harm caused to the patient. There were no patient complication, death or serious injury reported. There was no medical/surgical intervention required.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6803868
MDR Text Key246309266
Report Number1219856-2017-00181
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17B0020
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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