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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 Problems Fitting Problem (2183); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via field service report l700207.While during use on a patient, the intra-aortic balloon pump (iap) fiber optic sensor (fos) sensor comes out of the pump too easily.The pump was checked by the field service engineer and the reported complaint could not be duplicated.The fos connector was replaced as a precaution.The pump was switched off the patient to finish therapy.There were no patient complications reported.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "fos sensor easily comes out of the pump" is not confirmed.The fos slide assembly passed visual and functional test specifications.The root cause of the complaint is undetermined.No further action required.
 
Event Description
It was reported via field service report l700207.While during use on a patient, the intra-aortic balloon pump (iap) fiber optic sensor (fos) sensor comes out of the pump too easily.The pump was checked by the field service engineer and the reported complaint could not be duplicated.The fos connector was replaced as a precaution.The pump was switched off the patient to finish therapy.There were no patient complications reported.
 
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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
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 Key7172153
MDR Text Key96719251
Report Number1219856-2018-00010
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0700
Other Device ID Number00801902084965
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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