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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 Device Alarm System (1012); Communication or Transmission Problem (2896); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2017
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of triggering issues 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.
 
Event Description
It was reported the rn called the clinical support specialist (css) and stated they had a patient on bypass and they were having trouble getting the pump up and running. The rn stated the fiber optic sensor (fos) was connected and the bulb was green. The rn was slaving the electrocardiogram (ecg) from the anesthesia monitor. The arterial pressure was flat. The css had her change the pump back to autopilot and disconnect the ecg cable. The rn stated the flashing heart was irregular and the pump would only pump intermittently. The css explained that they were having triggering issues and discussed possible causes. During the discussion, the surgeon removed the balloon and asked for another one. Patient outcome: meeting goals of therapy. There was no reported death or serious injury to the patient. There was a report of delay in therapy but no complications caused to the patient.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the rn called the clinical support specialist (css) and stated they had a patient on bypass and they were having trouble getting the pump up and running. The rn stated the fiber optic sensor (fos) was connected and the bulb was green. The rn was slaving the electrocardiogram (ecg) from the anesthesia monitor. The arterial pressure was flat. The css had her change the pump back to autopilot and disconnect the ecg cable. The rn stated the flashing heart was irregular and the pump would only pump intermittently. The css explained that they were having triggering issues and discussed possible causes. During the discussion, the surgeon removed the balloon and asked for another one. Patient outcome: meeting goals of therapy. There was no reported death or serious injury to the patient. There was a report of delay in therapy but no complications caused to the patient.
 
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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.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6795467
MDR Text Key248235923
Report Number1219856-2017-00176
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
Report Date 07/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16F0021
Other Device ID Number00801902007247
Was Device Available for Evaluation? Yes
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? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2016
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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