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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
Model Number IPN001112
Device Problems Image Display Error/Artifact (1304); Failure to Read Input Signal (1581)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).For complaint involving the same patient and event see mdr #3010532612-2020-00100 and (b)(4).
 
Event Description
It was reported by the registered nurse that the intra-aortic balloon (iab) catheter was inserted without difficulty, fiber optic arterial pressure (ap) waveform was present, zeroed, but the waveform was "not normal" and fiber optic messages including calibration key missing and corrupt continued to happen.The rn exchanged the intra-aortic balloon pump (iabp) but still had the same issues.As a result, a second iab catheter was inserted into the same insertion site.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn#: (b)(4).No iap part was returned to teleflex chelmsford for investigation.The reported complaint of ap signal loss is confirmed based on the customer photo of the alarm history submitted in the complaint; however, a field service agent serviced the pump and could not be reproduce the issue.The pump passed functional checkout.The root cause of the 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: for complaint involving the same patient and event see mdr #3010532612-2020-00100 and tc #: (b)(4).
 
Event Description
It was reported by the registered nurse that the intra-aortic balloon (iab) catheter was inserted without difficulty, fiber optic arterial pressure (ap) waveform was present, zeroed, but the waveform was "not normal" and fiber optic messages including calibration key missing and corrupt continued to happen.The rn exchanged the intra-aortic balloon pump (iabp) but still had the same issues.As a result, a second iab catheter was inserted into the same insertion site.There was no report of patient complications, serious injury or death.
 
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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 Key9953981
MDR Text Key187560856
Report Number3010532612-2020-00104
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902084966
UDI-Public30801902084966
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 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN001112
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/24/2020
Initial Date FDA Received04/13/2020
Supplement Dates Manufacturer Received05/13/2020
Supplement Dates FDA Received05/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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