MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0500

Device Problems Loose or Intermittent Connection (1371); Gas/Air Leak (2946); Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp)had a moister error and possible purge error upon start-up.The iabp was sent to biomed to be serviced.Functional checks were performed on the iabp and all functional checks passed.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

Qn#(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of iabp purge failure alarm is not able to be confirmed.A teleflex field service engineer serviced the pump and could not duplicate the alarm.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot 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 moister error and possible purge error upon start-up.The iabp was sent to biomed to be serviced.Functional checks were performed on the iabp and all functional checks passed.There was no report of patient complication or serious injury and death.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8850898
• MDR Text Key: 152944227
• Report Number: 3010532612-2019-00237
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1