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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 Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)
Patient Problem No Information (3190)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) gave a purge failure alarm and blood backed into the system.As a result, the iabp was swapped out.There was no information provided regarding the patient outcome.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) gave a purge failure alarm and blood backed into the system.As a result, the iabp was swapped out.There was no information provided regarding the patient outcome.
 
Manufacturer Narrative
(b)(4).No iabp parts were returned to teleflex chelmsford for investigation.The reported complaint of the purge failure alarm is confirmed.The field service engineer found blood inside the pump, which is likely the cause of the alarm.The field service engineer replaced all contaminated parts.The root cause of the complaint is undetermined.Blood can only enter the iabp from an iab that develops a leak.The ifu states: "intra-aortic balloon membrane perforation may occur during iabp therapy.The occurrence and severity of the iab perforation is unpredictable and may be due to patient physiology, accidental contact with a sharp instrument or by contact with calcified plaque resulting in membrane surface abrasion and eventual perforation.Large perforations are rare.Small perforations can result in asymptomatic release of gas.Perforation can cause blood to appear in the balloon catheter and driveline tubing." 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.
 
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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 Key10431316
MDR Text Key203673320
Report Number3010532612-2020-00230
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,foreig
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
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? Yes
Date Manufacturer Received09/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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