MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-CAL 370; SYSTEM, THERMAL REGULATING

Model Number 95161-000

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

The product was serviced by the facility's bio med.Medtronic requested additional information regarding the water source and cleaning protocols the facility was using with the bio cal, but no response was received.

Event Description

Medtronic received information that during setup the liquid level sensor on this bio cal instrument didn't function correctly.The instrument was replaced with a backup unit and there was no patient involvement in the event.Medtronic service depot personnel provided the customer with ordering information for a replacement level sensor.The facility's bio med planned to perform the repair once the part was received.Medtronic requested additional information regarding the water source and cleaning protocols the facility was using with the bio cal, but a response was not received.

Manufacturer Narrative

Medtronic's investigation determined that the hospital is using tap water in the bio cal instrument.The ice used is also produced from a tap water source.The facility¿s water usage does not meet the requirement of the operator¿s manual, which specifically recommends the use of de-ionized water.

Event Description

Medtronic received information that during setup prior to use, the liquid level sensor on this bio cal instrument required replacement.The instrument was changed out with a backup and there was no resulting adverse patient effect.Depot service provided the customer the part number of the liquid level sensor to order.Product return is not expected as repair will be performed by customer.Nothing further was required by the customer.Additional information was later received indicating that tap water is used in the instrument.The ice used in the instrument is also produced from tap water.Per the ifu, de-ionized water should be used in the bio cal.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIO-CAL 370
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6167151
• MDR Text Key: 62344372
• Report Number: 2184009-2016-00039
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95161-000
• Device Catalogue Number: 95161-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1