MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL; INTRA- AORTIC BALLOON

Catalog Number CARDIAC UNKNOWN

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call.The cardiac care unit (ccu) registered nurse (rn) was calling to troubleshoot a loss of arterial pressure (ap) waveform on the pump.The pump has continued to pump without interruption in autopilot mode, pattern trigger, 1:1, with no other issues or alarms.Initially, the rn was assuming it was a fiber optic intra-aortic balloon (iab), but it is not.The central lumen arterial line (a-line) waveform is not present.The rn has no other available ap source.The clinical support specialist (css) explained the weissler timing method to the rn and discussed that he should discuss options with the doctor.If they will be weaning and removing the iab soon then the doctor may choose to continue as is.But if the patient is in need of support, then they should insert a radial a-line if unable to clear the central lumen.The css discussed troubleshooting, flushing in standby, etc., with the rn.He is likely going to request a radial to be inserted.Heparinized saline was used in the central lumen flush.The device was not removed or replaced.The patient is currently stable and supported on the pump.There was no reported patient death, injury or complications.There was no delay/interruption in therapy.How was issue resolved: a-line troubleshooting likely insertion of radial.Length of time in use prior to event: inserted earlier in the day.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for analysis therefore the reported complaint of central lumen occluded is not able to be confirmed.The root cause of the complaint is undetermined.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The reported complaint will be monitored for developing trends.

Event Description

It was reported via a hot line call.The cardiac care unit (ccu) registered nurse (rn) was calling to troubleshoot a loss of arterial pressure (ap) waveform on the pump.The pump has continued to pump without interruption in autopilot mode, pattern trigger, 1:1, with no other issues or alarms.Initially, the rn was assuming it was a fiber optic intra-aortic balloon (iab), but it is not.The central lumen arterial line (a-line) waveform is not present.The rn has no other available ap source.The clinical support specialist (css) explained the weissler timing method to the rn and discussed that he should discuss options with the doctor.If they will be weaning and removing the iab soon then the doctor may choose to continue as is.But if the patient is in need of support, then they should insert a radial a-line if unable to clear the central lumen.The css discussed troubleshooting, flushing in standby, etc., with the rn.He is likely going to request a radial to be inserted.Heparinized saline was used in the central lumen flush.The device was not removed or replaced.The patient is currently stable and supported on the pump.There was no reported patient death, injury or complications.There was no delay/interruption in therapy.How was issue resolved: a-line troubleshooting likely insertion of radial.Length of time in use prior to event: inserted earlier in the day.

• Brand Name: CARDIAC UNKNOWN DUMMY MATERIAL
• Type of Device: INTRA- AORTIC BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6600497
• MDR Text Key: 76254847
• Report Number: 1219856-2017-00115
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

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: CARDIAC UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1