MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX SP90

Model Number	944-157
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation showed that number 9 waste pouch was mounted in misaligned position.
Event or Problem Description
The customer experienced liquid leakage from abl90 solution pack during abl90 working.A medical worker got in touch with the leaked liquid, which may contain blood.He got liquid on his hand, his suits, his socks and his bag.
Additional Manufacturer Narrative
Information has been received that the medical worker, that came into contact with blood has not yet received any medical examination, but will be examined within a few months.

• Brand Name: ABL90 FLEX SP90
• Common Device Name: ABL90 FLEX SP90
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 6939631
• Report Number: 3002807968-2017-00034
• Device Sequence Number: 692129
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: (01)05700699441577(17)171223(10)YN55
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2017
• Device Model Number: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: YN55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1