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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 Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/05/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) had a high baseline and system error 3 alarm while on patient.As a result, the iabp was swapped out quickly without any patient issues.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4) teleflex received the device for investigation.The reported complaint of "high baseline and system error 3 alarm" is confirmed.A loose connector pin on the output cable was noted which was the result of the alarms.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.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) had a high baseline and system error 3 alarm while on patient.As a result, the iabp was swapped out quickly without any patient issues.There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) had a high baseline and system error 3 alarm while on patient.As a result, the iabp was swapped out quickly without any patient issues.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "high baseline and system error 3 alarm" is confirmed.During the investigation, the returned m-force motor driver assembly was installed in a pump and alarmed for "system error 3".A loose connector pin on the output cable of the m-force was noted, and caused the alarms.A non-conformance has been initiated to further investigate the issue.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.
 
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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 Key11367781
MDR Text Key242462397
Report Number3010532612-2021-00041
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,Followup
Report Date 02/05/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Initial Date Manufacturer Received 02/05/2021
Initial Date FDA Received02/23/2021
Supplement Dates Manufacturer Received03/26/2021
05/27/2021
Supplement Dates FDA Received04/01/2021
06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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