MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0400

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For complaint related to the same event/patient see mdr #3010532612-2019-00278 and (b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) did not alarm when blood was noted inside the balloon.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon pump (iabp) did not alarm when blood was noted inside the balloon.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4) for complaint related to the same event/patient see mdr #3010532612-2019-00278 and (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp did not alarm is not able to be confirmed.The product was not returned for investigation.The root cause of the complaint is undetermined.No lot number/serial number was reported, therefore, a device history record (dhr) review was unable to be completed.The lot number history for this account was unable to be retrieved.If the lot number information is available at a later date, the complaint will be updated accordingly.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

• Brand Name: AUTOCAT 2
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8898493
• MDR Text Key: 154579732
• Report Number: 3010532612-2019-00306
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

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 Catalogue Number: IAP-0400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 65