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

Catalog Number IAP-0500

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Cardiogenic Shock (2262)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call.The md is calling to troubleshoot a pump that "will not pump." they have just inserted a (iab) intra-aortic catheter at bedside.The md reported a purge failure alarm.The catheter is connected, helium tank is open and 3/4 full, there are (ap)arterial pressure waveforms and (ecg) electrocardiogram tracing in place, there is a red blinking heart and when pump on was pressed a system error one alarm occurred.The clinical support specialist had them power off and power back on the pump and a system error one alarm immediately occurred.The css advised that they exchange the pump.The second pump was connected with minimal delay and is now supporting the patient.The css discussed the map cal with them.The md reported that the waveforms look good, the pump is achieving the goals of therapy and he has no additional questions at this time.The css provided her direct number should they have additional questions of problems @ 2113 est- call from administration- concerned that they have no pumps available since they pulled one from service.The css spoke to the sales rep.As well as the field service agent who followed up on the pump that was removed.It was reported via a field service report: (b)(4).Symptom: system error 1 findings / action taken: found system error 1 upon power up.Replaced the pcs assembly.Found loose connection at cable (b)(4) at (fe bd) front end board end repair system functional.(b)(6) level: (b)(4), software level: (b)(4), expedited qa review: yes.Op = on patient.Confirmed.

Manufacturer Narrative

(b)(4) the pcs assembly (p/n 96-3006-001w, s/n (b)(4)) was returned for evaluation.Visual inspection of the pcs assembly was performed and no abnormality was found.The pcs assembly in question was installed into known good autocat2w and performed functional testing.The known good autocat2w with the pcs assembly in question installed passed the functional test.The purge cycle was performed multiple times with no alarms or errors.The pump was then left to run for over six hours without any issues.The pcs assembly in question was installed onto the mdt-50 leak tester and passed leak testing.Visual inspection of the pcs assembly internal hardware was performed and no abnormality was found.Conclusion: the report problem of "alarm, system error 1 and purge failure" is confirmed based on the fse finding of loose cable connection.The fse re-connected the cable and that fixed the problem.The pcs assembly was replaced for reassurance.The pcs assembly passed functional testing.The cause of loose connection is undetermined.

Event Description

It was reported via a hot line call.The md is calling to troubleshoot a pump that "will not pump." they have just inserted a (iab) intra-aortic catheter at bedside.The md reported a purge failure alarm.The catheter is connected, helium tank is open and 3/4 full, there are (ap)arterial pressure waveforms and (ecg) electrocardiogram tracing in place, there is a red blinking heart and when pump on was pressed a system error one alarm occurred.The clinical support specialist had them power off and power back on the pump and a system error one alarm immediately occurred.The css advised that they exchange the pump.The second pump was connected with minimal delay and is now supporting the patient.The css discussed the map cal with them.The md reported that the waveforms look good, the pump is achieving the goals of therapy and he has no additional questions at this time.The css provided her direct number should they have additional questions of problems.At 2113 est- call from administration- concerned that they have no pumps available since they pulled one from service.The css spoke to the sales rep.As well as the field service agent who followed up on the pump that was removed.It was reported via a field service report: (b)(4).Symptom: system error 1.Findings / action taken: found system error 1 upon power up.Replaced the pcs assembly.Found loose connection at cable 77-3746-001 at (fe bd)front end board end repair system functional.Fcn level: 1416, software level: 2.24.Expedited qa review: yes.Op = on patient.Confirmed.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5763437
• MDR Text Key: 48630603
• Report Number: 1219856-2016-00144
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1