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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0700
Device Problem Failure to Zero (1683)
Patient Problem No Information (3190)
Event Date 02/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).This would not be likely to cause or contribute to a death or serious injury, and if it were to reoccur, it would be unlikely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.
 
Event Description
It was reported that prior to use on a patient, the staff noted that the intra-aortic balloon pump (ibap) had a failed fos.The staff stated that when the cal key was inserted, they got the yellow on the checklist but no audible tones.The staff then got another iabp and got the same results.The staff then got another intra-aortic balloon (iab) and same results occurred with the first iabp (no audible tones), on the second iabp the staff did get the double tones and zeroed appropriately.No information was provided regarding patient condition.
 
Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "yellow on the checklist but no audible tones" is not confirmed.The returned fos board and fos slider were installed and powered on using an ac3, the fos status was "ok" with an audible tone; however, the fos board failed fos pressure test.The root cause of this 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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Other remarks: this would not be likely to cause or contribute to a death or serious injury, and if it were to reoccur, it would be unlikely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.
 
Event Description
It was reported that prior to use on a patient, the staff noted that the intra-aortic balloon pump (ibap) had a failed fos.The staff stated that when the cal key was inserted, they got the yellow on the checklist but no audible tones.The staff then got another iabp and got the same results.The staff then got another intra-aortic balloon (iab) and same results occurred with the first iabp (no audible tones), on the second iabp the staff did get the double tones and zeroed appropriately.No information was provided regarding patient condition.
 
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Brand Name
AC3 OPTIMUS IABP NA/EMEA
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11416670
MDR Text Key240371527
Report Number3010532612-2021-00064
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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